BIOFLEX PEACE Registry
|
|
- Angelica Fields
- 6 years ago
- Views:
Transcription
1 BIOFLEX PEACE Registry Pulsar Efficacy: an All Comers Registry INTERIM ANALYSIS Michael K. W. Lichtenberg On behalf of the BIOFLEX-PEACE study group
2 Definition and understanding of various radial forces Radial force at expansion is also known as Chronic Outward Force (COF). COF Stent nominal diameter of 7mm 7mm stent expanding into a 6mm vessel Original plaque (post lesion preparation) 6mm vessel Radial force under compression is also known as Radial Resistive Force (RRF). RRF Simulating concentric restenosis Neointimal hyperplasia 6mm vessel Crush Resistance (CR) is also force under compression but at a focal point CR Simulating eccentric restenosis Neointimal hyperplasia 6mm vessel Source: Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol Jul;32(4):720-6
3 Correct chronic outward force (COF) Low COF = lower mechanical stress on vessel wall IIB(P)71/ test report, Institute fuer ImplantTechnologie und Biomaterialien e.v., Rostock-Warnemuende
4 Sufficient Crush resistance If too low = stent collapse 50 % 25 % 10 % IIB(P)71/ test report, Institute fuer ImplantTechnologie und Biomaterialien e.v., Rostock-Warnemuende
5 Link between scientific theory and proven clinical benefit: clinical trials Safety /Efficacy Required stent design /characteristics Long term patency Low TLR rate 4 F device w/o need of closure device Low compression time Ideal radial resistive force (RRF) Ideal chronic outward force (COF) Ideal crush resistance (CR)
6 4-EVER and PEACE Two Trials Looking Into 4F Self Expanding Stents in the SFA Primary Patency Baseline 12mt 24mt 4 EVER 100% 81.4% 72.3% PEACE 100% 79.5% N/A 4-EVER 1 (Savety and Efficacy) Prospective, Multicenter, non randomized trial, Belguim 120 pts 72.42mm Mean Lethion Lenght TASC (70% A, 22.5% B, 7.5% C, 0% D) Demographics (35.8% Diabethic, 41.7% current Smoker, 16.7%LI, 20.8%CTO) 89.3% ftlr at 12mth No closure device needed and short mean manual compression time of 8.1min PEACE 2 (Registry) Prospective, Multicenter, non randomized trial, Germany 148 pts 111.5mm Mean Lethion Lenght TASC (18.7% A, 23.6% B, 19.4% C, 32.2% D) Demographics (31%Diabethic, 37% current Smoker, 68.7% LI, 56.7% CTO) 81% ftlr at 12mth No significant patency difference at 12mth between TASC A/B vs. C/D or between patients with Rutherford <3 vs. >3 1.) Journal of Endovascular Therapy 2013;20: ) Journal of Endovascular Therapy 2014;21:
7 Study design and participating centers Objective: Evaluation of safety and performance of Pulsar-18 in treatment of subjects with atherosclerotic disease Design: Prospective, non-randomized, multi-centre All Comers Registry with follow-up investigations at 6, 12 and 24 months Indication: Subjects with infrainguinal atherosclerotic disease eligible for stent implantation Dr. Michael Lichtenberg (PI), Arnsberg Prof. Dr. Guenther Wittenberg (Bielefeld) Dr. Tessarek (Lingen) Prof. Holger Reinecke (Münster) Dr. Stefan Betge (Jena) Dr. Torsten Fuss (Suhl) Prof. Dr. Sigrid Nikol (Hamburg) Prof. Dr. Claus Nolte-Ernsting (Mülheim) Dr. Jawed Arjumand (Wuppertal) PD Dr. med. Ulrich Sunderdiek (Osnabrück) Prof. Dr. Birgit Hailer (Essen) Dr. Jawed Arjumand (Wuppertal) Up to 200 patients with SFA /APOP lesions in 12 clinical sites in Germany Enrollement startet 07/2014 BIOTRONIK 4F Pulsar - 18 SE Stent In combination with atherectomy, scoring and cutting balloon angioplasty, DCB 6 month follow up, clinical success, complications 12 month follow up, clinical success, complications 24 month follow up, clinical success, complications
8 Inclusion criteria: Registry design Rutherford 2-5 SFA APOP Seg. III stenosis > 50 % with clinical indication for treatment Target vessel reference diameter 2.5 to 6 mm No lesion length restriction No restriction of stent numbers Exclusion criteria: Treatment failure, subjects pregnant or planning to become pregnant, life expectancy < 1 year, subject enrolled in another study Primary / secondary endpoints Primary patency of the Pulsar-18 SE stent at 6,12 and 24 months: Defined as a binary duplex ultrasound ratio (PSVR) < 2,5 at the stented target lesion(s) No clinically driven re-intervention within the stented segment(s) (freedom from target lesion revascularization) Estimation of limb salvage
9 BIOFLEX PEACE Registry Subgroup analysis Type of stenosis (e.g. de novo, restenotic, etc.) Lesion length, location, degree of stenosis, calcification TASC classification Lesion preparation (e.g. scoring balloons, cutting balloons, atherectomy devices, etc.) Use of Drug eluting balloons for predilatation for postdilatation Stent characteristics (diameter, length, overlapping, etc.) Treatment approach (e.g. sub-intimal, intra-luminal, etc.) Stenting strategy (e.g. spot stenting, etc.) QoL (e.g. pain level, WIQ, SF-12)
10 Consort Chart of first 179 Patients First 179 consecutive subjects Jul Nov 2015 Upcoming 6mt FUP 16 Missed Visit 25 LTFU 0 Withdrawal 9 Patient Death Patients at 6 month FUP
11 Patients and lesions characteristics at baseline Patients N = 126 Lesion characteristics N = 144 Male 70 (55.6%) Age Median (Min/Max) 73 (47/89) Hypertension 114 (90.5%) Dyslipidemia 102 (81.0%) Current smoker 41 (32.5%) Diabetes 44 (34.9%) Renal Insufficiency 27 (21.4%) Rutherford* (1.6%) 55 (45.1%) 41 (33.6%) 12 (9.8%) 11 (9.0%) 1 (0.8%) Ankle brachial index (n=100) 0.65 ± 0.14 Walking capacity (m) (n=33) ± 90.0 Lesion length (mm) (n=143) ± TASC A lesion 34 (23.6%) TASC B lesion 48 (33.3%) TASC C lesion 27 (18.8%) TASC D lesion 35 (24.3%) Calcification 0 (no calcification) 1 (minimal) 2 (moderate) 3 (severe) Moderate & Severe 26 (18.1%) 60 (41.7%) 32 (22.2%) 26 (18.1%) 58 (40.3%) Femoral Artery 124 (86.1%) Popliteal Artery 19 (13.2%) PTA 1 (0.7%) * 4 patient without classification because of missing data
12 Freedom from MAE Subgroup Analysis (126 Subjects at 6 month) Freedom from MAE % (N/Ntot) (Target Lesion Restenosis or Target Lesion Revascularisation) MAE (first 126 subjects at 6mth) 91.3% (115/126) Diabetic patients MAE at 6mth FUP 93.2% (41/44) Non Diabetic patients MAE at 6mth FUP 90.2% (74/82) Lesion length > 100 mm MAE at 6mth FUP 85.5% (53/62)* Lesion length < 100 mm MAE at 6mth FUP 96.8% (61/63)* Popliteal segment (I III) MAE at 6mth FUP 82.4% (14/17) * p=0,02990 (Fisher exact, two sided)
13 Kaplan-Meier Estimation freedom MAE fmae 91.1% at 6 month Time (Month) MAE defined Target Lesion Restenosis or Target Lesion Revascularisation Patients at Risk Day 0 6 Month (interim)
14 Kaplan-Meier Estimation ftlr Freedom from TLR 91.9% at 6 month Time (Month) Patients at Risk Day 0 6 Month (interim)
15 Efficacy Analysis (125 subjects at 6 month) N Average lesion length Primary Patency ftlr Overall ± mm 115 (91.3%) 116 (92.1%) POBA -> Stent ± mm 13 (92.9%) 13 (92.2%) POBA -> Stent -> POBA ± 67.3 mm 44 (93.6%) 44 (93.6%) DCB -> Stent -> POBA ± 83.2mm 31 (86.1%) 31 (86.1%) POBA -> Stent -> DCB ± mm 18 (90.0%) 19 (95.0%) others (Artherectomy soring balloon, cutting balloon, etc.) SFA ± mm 100 (92.6%) 101 (93.5%) Popliteal Artery ± 58.8 mm 10 (83.3%) 10 (83.3%) other
16 Change in Rutherford Index at 6 Month 87.6% improved by one or more Rutherford classes Worsening Unchanged or more Improvement
17 Conclusions The preliminary 6 month results of the BIOFLEX-PEACE Registry shows a Kaplan Meier Estimate of 91.1% MAE and of 91.9% freedom from TLR, with clinical success of 87.6% (improvement in Rutherford class 1) in lesions of average length of 99.8mm Subgroup analysis shows no statistical significant difference in primary patency between diabetic and non diabetic patients. Statistical significant difference was shown for primary patency between long and short lesions with favourable outcome for lesions <100mm over lesion longer than 100mm. Further evaluation of the entire study population with a follow up of one year or more is needed to give more defined insight to the subject.
18 Thank you for your attention
19 Study DEVICE Mean lesion length Primary patency Freedom from TLR 4EVER Pulsar mm 73.4 % 85.2 % PEACE I Pulsar mm 79.5 % 81.5 % TASC D Trial (CLI patients) Long SFA Trial (non CLI patients) Pulsar mm 77.0 % 86.0 % Pulsar mm 85.4 % 89.6 % Supera Supera 90 mm 84.7 % NA Resilient Lifestent 62 mm 81.3 % 87.3 % Zilver PTX DES Zilver 63 mm 73.0 % 77.0 % Durability Everflex 96 mm 72.2 % 79.1 % Durability 200 Everflex 242 mm 64.8 % 68.2 % Viabahn 200 Viabahn 194 mm 78.0 % 85.0 % 6 F
20 BIOFLEX PEACE Registry Pulsar Efficacy: an All Comers Registry INTERIM ANALYSIS Michael K. W. Lichtenberg On behalf of the BIOFLEX-PEACE study group
Pulsar stent technology
Pulsar stent technology Michael K. W. Lichtenberg Vascular Center Arnsberg Disclosures Speaker name: Michael Lichtenberg... I have the following potential conflicts of interest to report: X Consulting
More informationBioMimics 3D in my Clinical Practice
BioMimics 3D in my Clinical Practice M Lichtenberg M.D. Vascular Centre Arnsberg / German Venous Centre Arnsberg CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational
More informationInterventional options with modern 4F nitinol stents in SFA lesions
Interventional options with modern 4F nitinol stents in SFA lesions Michael Lichtenberg, FESC Vascular Center Sauerland TYPICAL VASCULAR PATIENT Multi vessel disease Diabetes, obese Age Diffuse sclerotic
More informationClinically proven. ordering info. Vascular Intervention // Peripheral Self-Expanding Stent System/0.018 /OTW. Pulsar-18
140 μm thin struts Clinically proven 4F low profile Vascular Intervention // Peripheral Self-Expanding Stent System/0.018 /OTW Pulsar-18 Technical data / ordering info 140 μm thin struts - thinner than
More informationMinimizing Burden, the effect of thin strut and low Chronic Outward Force SE stents
Minimizing Burden, the effect of thin strut and low Chronic Outward Force SE stents Prof. Yong LIU The affiliated hospital of southwest medical university LINC AP 2018, Hong Kong 13-15 th March Disclosure
More informationDisclosures. In the DCB Era, How Do I Choose To Use a Stent? When to Stent and What Devices to Use in the SFA
In the DCB Era, How Do I Choose To Use a Stent? When to Stent and What Devices to Use in the SFA Disclosures No financial disclosures. Cameron M. Akbari, MD, MBA, FACS Site Director, Vascular Surgery Medstar
More informationSFA lesion treatment: China experience. Wei Liang, MD
SFA lesion treatment: China experience Wei Liang, MD Disclosure I do not have any potential conflict of interest Background PAD: 14% - 20% in adults Aorta & Iliac A: 30% Femoral & Pop A: 80-90% Tibial
More informationREACT Treatment Rationale and Clinical Evidence. ICI Meeting 5th of December 2017
REACT Treatment Rationale and Clinical Evidence ICI Meeting 5th of December 2017 The SFA is a challenging vessel to treat Shortening 23-25%1 Compression > 1kg2 Torsion 60 3 Bending 64 4 SFA, superficial
More informationTOBA II 12-Month Results Tack Optimized Balloon Angioplasty
TOBA II 12-Month Results Tack Optimized Balloon Angioplasty William Gray, MD System Chief, Cardiovascular Division Main Line Health, Philadelphia, PA Dissection: The Primary Mechanism of Angioplasty Lesions
More informationOr is the ivolution stent a better alternative? EVOLUTION 12-month data
Or is the ivolution stent a better alternative? EVOLUTION 12-month data Dr. Marc Bosiers LINC 2018, Leipzig Conflict of interest have the following potential conflicts of interest to report: Consulting
More informationBIOLUX P-III Passeo-18 Lux All-comers Registry: 12-month Results for the All-Comers Cohort
BIOLUX P-III Passeo-18 Lux All-comers Registry: 12-month Results for the All-Comers Cohort Prof. Dr. Gunnar TEPE, Klinikum Rosenheim, Germany CCI on behalf of the BIOLUX P-III Investigators Disclosure
More informationDo we really need a stent in long SFA lesions? No: DEB is the answer
Do we really need a stent in long SFA lesions? No: DEB is the answer Thomas Zeller, MD University Heart-Center Freiburg-Bad Krozingen Bad Krozingen Germany My Disclosures: Advisory Board: Medtronic-Invatec,
More informationUpdate on the Levant 2 Clinical Trial Programme. Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany
Update on the Levant 2 Clinical Trial Programme Dierk Scheinert, MD University Hospital Leipzig Leipzig, Germany Disclosure Speaker name: Dierk Scheinert I have the following potential conflicts of interest
More informationChristian Wissgott MD, PhD Assistant Director, Radiology Westküstenkliniken Heide
2-Year Results Of The Tack Optimized Balloon Angioplasty (TOBA) Trial For Fem- Pop Lesions Demonstrates Safety and Efficacy Of The Tack Endovascular System In Repairing Focal Post-PTA Dissections Christian
More information4/14/2016. Faculty Disclosure. Drug-eluting technology in the SFA and Popliteal. Typical SFA Disease Pattern. Why Peripheral Artery Disease Matters
Drug-eluting technology in the SFA and Popliteal David Paul Slovut, MD, PhD Associate Professor of Medicine and Surgery Co-director of TAVR program Director of Advanced Intervention Faculty Disclosure
More informationEfficacy of DEB in Calcification and Subintimal Angioplasty
Efficacy of DEB in Calcification and Subintimal Angioplasty Seung-Woon Rha, MD, PhD, FACC, FAHA, FSCAI, FESC, FAPSIC Div of Cardiovascular Intervention and Research Cardiovascular Center, Korea University
More informationUpdate on the Ranger clinical trial programme
Update on the Ranger clinical trial programme Dierk Scheinert, MD Universitätsklinikum Leipzig, Leipzig, Germany on behalf of the RANGER SFA investigators Disclosure Speaker s name: Dierk Scheinert I have
More informationRANGER SFA REGISTRY Interim Analysis. Bernd Gehringhoff, MD On behalf the Ranger SFA Registry Investigators
RANGER SFA REGISTRY Interim Analysis Bernd Gehringhoff, MD On behalf the Ranger SFA Registry Investigators Conflict of Interest - Disclosure Within the past 12 months, I or my spouse/partner have had a
More informationWhich Stent Is Best for Various Femoropopliteal Anatomy? 2018 Pacific Northwest Endovascular Conference June 15-26, 2018 Seattle, WA
Which Stent Is Best for Various Femoropopliteal Anatomy? 2018 Pacific Northwest Endovascular Conference June 15-26, 2018 Seattle, WA Brian DeRubertis, MD, FACS Associate Professor of Surgery UCLA Division
More informationEffPac - Trial: Assessment of the Effectiveness of DCB versus POBA in the SFA Ulf Teichgräber, MD, MBA
EffPac - Trial: Assessment of the Effectiveness of DCB versus POBA in the SFA Ulf Teichgräber, MD, MBA Leipzig, 24.01.2017 Prof. Dr. Ulf Teichgräber - LINC 2017 2 Disclosure of conflict of interest Speaker
More informationThe Crack and Pave technique for highly resistant calcified lesions. Manuela Matschuck MD University Hospital Leipzig Department Angiology
The Crack and Pave technique for highly resistant calcified lesions Manuela Matschuck MD University Hospital Leipzig Department Angiology Disclosure Speaker name: Dr. med. Manuela Matschuck I have the
More informationMEET M. Bosiers K. Deloose P. Peeters. SFA stenting in 2009 : The good and the ugly What factors influence patency?
MEET 2009 SFA stenting in 2009 : The good and the ugly What factors influence patency? M. Bosiers K. Deloose P. Peeters 1 TASC II 2007 vs TASC 2000 Type A Type B Type C Type D 2000 < 3 cm 3-5 cm < 3 cm
More informationClinical Data Update for Drug Coated Balloons (DCB) Seung-Whan Lee, MD, PhD
Clinical Data Update for Drug Coated Balloons (DCB) Seung-Whan Lee, MD, PhD Asan Medical Center, Heart Institute, University of Ulsan College of Medicine, Werk et al. Circulation Cardiovasc Intervent 2012
More informationDrug-Coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort
Drug-Coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort a.o. Univ. Prof. Dr. Marianne Brodmann Medical University of Graz Graz,
More informationManagement of In-stent Restenosis after Lower Extremity Endovascular Procedures
Management of In-stent Restenosis after Lower Extremity Endovascular Procedures Piotr Sobieszczyk, MD Associate Director, Cardiac Catheterization Laboratory Cardiovascular Division and Vascular Medicine
More informationMaximizing Outcomes in a complex population with Drug-coated balloon
Maximizing Outcomes in a complex population with Drug-coated balloon March 13, 2018 Chumpol Wongwanit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand LINC Asia-Pacific 2018, Hong Kong Disclosure
More information2-YEAR DATA SUPERA POPLITEAL REAL WORLD
2-YEAR DATA SUPERA POPLITEAL REAL WORLD Enrique M. San Norberto. Angiology and Vascular Surgery. Valladolid University Hospital. Valladolid. Spain. Disclosure Speaker name: ENRIQUE M. SAN NORBERTO I have
More informationNew Data to Shape the Era of Drug Elution in Peripheral Interventions
New Data to Shape the Era of Drug Elution in Peripheral Interventions William A. Gray MD Director of Endovascular Services Columbia University Medical Center New York Lower Extremity Endovascular - Interventions
More informationDCB use in fem-pop lesions of patients with CLI (RCC 4-5): subgroup analysis of IN.PACT Global 12-month outcomes
DCB use in fem-pop lesions of patients with CLI (RCC 4-5): subgroup analysis of IN.PACT Global 12-month outcomes Carlos Mena, MD FACC FSCAI Associate Professor of Medicine - Cardiology Director Cardiac
More informationLutonix DCB in BTK Update on the BTK real world registry and RCT
Lutonix DCB in BTK Update on the BTK real world registry and RCT Prof. Dr. med. Dierk Scheinert Department of Interventional Angiology University Hospital Leipzig Disclosures Speaker: Prof. Dr. med. Dierk
More informationCould a combination of DCB + stent be the answer in complex SFA lesions
Could a combination of DCB + stent be the answer in complex SFA lesions Sven Bräunlich, MD Division of Interventional Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Sven Bräunlich
More informationMichael K.W. Lichtenberg, MD
Ranger All-Comer Registry Treatment of femoropopliteal atherosclerotic lesions using the Drug eluting Balloon Ranger: An All Comers Registry Michael K.W. Lichtenberg, MD Klinikum Arnsberg Arnsberg, Germany
More informationThe ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Dr. Sven Bräunlich Department of Angiology University-Hospital Leipzig, Germany Disclosure Speaker
More informationDisclosures. Rational Selection of Endovascular Options for the SFA and Popliteal: What Works Where and for How Long?
Rational Selection of Endovascular Options for the SFA and Popliteal: What Works Where and for How Long? UCSF Vascular Symposium 2017 April 6-8, 2017 San Francisco, CA Disclosures Consulting, Speakers
More informationLong Lesions: Primary stenting or DCB first? John Laird MD Adventist Heart and Vascular Institute, St. Helena, CA
Long Lesions: Primary stenting or DCB first? John Laird MD Adventist Heart and Vascular Institute, St. Helena, CA Disclosures John R. Laird Within the past 12 months, I or my spouse/partner have had a
More information12-month Outcomes of Post Dilatation in the IN.PACT Global CTO Cohort. Gunnar Tepe, MD RodMed Clinic Rosenheim Rosenheim, Germany
12-month Outcomes of Post Dilatation in the IN.PACT Global CTO Cohort Gunnar Tepe, MD RodMed Clinic Rosenheim Rosenheim, Germany Disclosure Speaker name: Gunnar Tepe I have the following potential conflicts
More informationCutting/scoring balloon Cryoplasty Drug-eluting balloon Brachytherapy Debulking Restent (BMS or DES) John R. Laird, MD
Current Treatment of Femoropopliteal Instent Restenosis Professor of Medicine Medical Director of the Vascular Center UC Davis Medical Center SFA In-stent Restenosis Common: 18%- 40% at 12 months in recent
More informationLatest Insights from the LEVANT II study and sub-group analysis
Latest Insights from the LEVANT II study and sub-group analysis Prof. Dr. med. Dierk Scheinert Division of Interventional Angiology University-Hospital Leipzig, Germany Conflicts of Interest Advisory Board
More informationIs a Stent or Scaffold Necessary in The SFA?
1 2 3 Is a Stent or Scaffold Necessary in The SFA? Stents were developed to optimize acute results after angioplasty Specifically, stents are universally accepted to manage flow limiting dissections and
More informationOutcomes Of DCB Use In Real World Registries: 2 Year Results From The INPACT Global Registry
Outcomes Of DCB Use In Real World Registries: 2 Year Results From The INPACT Global Registry Marianne Brodmann, MD Head of the Clinical Division of Angiology Department of Internal Medicine Medical University
More informationLuminor DCB in femoropopliteal lesions
Luminor DCB in femoropopliteal lesions EffPac trial results and solo DCB study design Marcus Thieme, MD Department of Angiology/ Cardiology/ Diabetology Regiomed Vascular Center Sonneberg Clinic for Internal
More informationSUPERSUB Trial: 1-yr outcomes of SUPERa SUBintimal stenting in CLI Patients
SUPERSUB Trial: 1-yr outcomes of SUPERa SUBintimal stenting in CLI Patients Dr. L.M. Palena, MD Interventional Radiology Unit Foot & Ankle Clinic Policlinico Abano Terme (PD), ITALY Disclosure I have the
More informationAtherectomy: Jetstream and Directional. George S. Chrysant, M.D.
Atherectomy: Jetstream and Directional George S. Chrysant, M.D. Disclosures Abbott Vascular: MAB, consultant, proctor Abiomed: consultant Boston Scientific: MAB, consultant, proctor Medicines Company:
More informationUpdate in femoral angioplasty & stenting PRO
MEET 2008 Update in femoral angioplasty & stenting Will extra-long stents be a solution for SFA disease? PRO Patrick Peeters, MD Chief department Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden,
More informationCurrent Status and Limitations in the Treatment of Femoropopliteal In-Stent Restenosis
Current Status and Limitations in the Treatment of Femoropopliteal In-Stent Restenosis Osamu Iida, MD From the Kansai Rosai Hospital Cardiovascular Center, Amagasaki City, Japan. ABSTRACT: Approximately
More informationTools and options for recanalisation of long-femoro-popliteal segments
Tools and options for recanalisation of long-femoro-popliteal segments Pr E Ducasse Unit of Vascular Surgery University of Bordeaux ESVB 2011-may 14th E Ducasse, G Sassoust, D Midy THE ACCESS!! Retrograde
More informationA Data-driven Therapeutic Algorithm For Choosing Among Currently Available Tools For SFA Intervention
A Data-driven Therapeutic Algorithm For Choosing Among Currently Available Tools For SFA Intervention William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine Columbia
More informationAccurate Vessel Sizing Drives Clinical Results. IVUS In the Periphery
Accurate Vessel Sizing Drives Clinical Results IVUS In the Periphery Discussion Iida O, et. al. Study Efficacy of Intravascular Ultrasound in Femoropopliteal Stenting for Peripheral Artery Disease With
More informationPreliminary 12 Months results of the RAPID trial
Preliminary 12 Months results of the RAPID trial Multi-center Randomised trial of Legflow DEB supported stenting vs. stenting alone in intermediate and long SFA lesions Daniel van den Heuvel, MD On behalf
More informationDrug-coated balloons in BTK:
Drug-coated balloons in BTK: Where do we stand and what are the open questions? Dr. Marc Bosiers LINC 2019 - Leipzig My disclosures x o I do not have any potential conflicts of interest to report o I have
More informationThe Final Triumph Of Endovascular Therapy In SFA Treatment
The Final Triumph Of Endovascular Therapy In SFA Treatment MEET 07 Mark W. Mewissen, M.D. Director, St Lukes Vascular Center Milwaukee, WI Endovascular Therapy In SFA Treatment: Works In Progress! Mark
More informationWhen Outcomes Matter, Design Matters
to receive our latest news and key activities. Cordis S.M.A.R.T. Self-Expanding Nitinol Lower Extremity Solutions When Outcomes Matter, Design Matters For superficial femoral artery (SFA) and iliac lesions.
More informationLessons learnt from DES in the SFA is there any ideal concept so far?
Wednesday, January 25, 2017 - Time: 11:49-11:55 DEEP DIVE SESSION: Lower limb interventions (part II) Lessons learnt from DES in the SFA is there any ideal concept so far? S.Müller-Hülsbeck, MD, EBIR,
More informationTOBA Trial 12 months Results
Tack Optimized Balloon Angioplasty: TOBA Trial 12 months Results New Paradigm for Managing Post PTA Dissections Marc Bosiers, MD A.Z. St. Blasius Hospital, Belgium Disclosure Speaker name: Dr. Marc Bosiers
More informationComparison Of Primary Long Stenting Versus Primary Short Stenting For Long Femoropopliteal Artery Disease (PARADE)
Comparison Of Primary Long Stenting Versus Primary Short Stenting For Long Femoropopliteal Artery Disease (PARADE) Young-Guk Ko, M.D. Severance Cardiovascular Hospital, Yonsei University Health System,
More informationSpecificities for infrapopliteal stents
Specificities for infrapopliteal stents Nicolas Diehm, M.D. Swiss Cardiovascular Center Clinical and Interventional Angiology University Hospital Bern, Switzerland Disclosures Speaker`s Bureau: MEDRAD,
More informationHiroshi Ando, MD Kasukabe Chuo General Hospital Saitama, Japan
Hiroshi Ando, MD Kasukabe Chuo General Hospital Saitama, Japan Disclosure Hiroshi Ando, MD Kasukabe Chuo General Hospital I have the following potential conflicts of interest to report: Consulting Employment
More informationLong-term results with interwoven nitinol stents vs. BMS vs. DCB
Long-term results with interwoven nitinol stents vs. BMS vs. DCB Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany Disclosure Advisory Board /Consultant: Abbott,
More informationAdvancing treatment in highly complex lesions evidence and practice. Arne Schwindt St. Franziskushospital Münster
Arne Schwindt St. Franziskushospital Münster Disclosure Speaker name: Arne Schwindt I have the following potential conflicts of interest to report: x Consulting: Avinger, Biotronik, Cordis, Covidien, Jotec,
More informationThe latest generation DEB
The latest generation DEB V. Riambau, MD. PhD Prof. and Chief of Vascular Surgery Division, Cardiovascular Institute, Hospital Clínic of Barcelona University of Barcelona Consultant: Bolton Medical/ Medtronic/
More informationThe ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report
The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report G. Biro, M. Bosiers on behalf of ZILVERPASS Study Group Disclosure Speaker
More informationDierk Scheinert, MD. Department of Angiology University Hospital Leipzig, Germany
The RANGER clinical trial programme: 12-month results from the RANGER RCT and first look at the COMARE I study of RANGER vs. IN.PACT for femoropopliteal lesions Dierk Scheinert, MD Department of Angiology
More informationThe latest evidences from the DES trials in peripheral arterial disease
The latest evidences from the DES trials in peripheral arterial disease Michael D. Dake, MD Thelma and Henry Doelger Professor Stanford University School of Medicine Disclosure Speaker name: Michael D.
More informationIs combination therapy with directional atherectomy followed by DCB the answer to challenges in treating SFA disease?
Is combination therapy with directional atherectomy followed by DCB the answer to challenges in treating SFA disease? The REALITY trial G. Torsello Münster Disclosure Speaker name: G. Torsello... I have
More informationClinical benefits on DES Patient s perspectives
Clinical benefits on DES Patient s perspectives Dr. Skyi Pang Vascular Surgeon Department of Surgery Pamela Youde Nethersole Eastern Hospital Hong Kong Disclosure Speaker name: Skyi Pang... I have the
More informationAngiographic dissection pattern and patency outcomes of post balloon angioplasty for SFA lesions -a retrospective multi center analysis-
Angiographic dissection pattern and patency outcomes of post balloon angioplasty for SFA lesions -a retrospective multi center analysis- Masahiko Fujihara Kishiwada Tokushukai Hospital, Osaka, Japan Disclosure
More informationReal PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions
Real PTX RCT: 3 year data from a randomized comparison of DCB vs. DES in femoropopliteal lesions Dierk Scheinert, MD Department of Angiology University of Leipzig, Germany Disclosure Dierk Scheinert, MD
More informationPromise and limitations of DCB in long lesions What Have we Learned from Clinical Trials? Ramon L. Varcoe, MBBS, MS, FRACS, PhD
Promise and limitations of DCB in long lesions What Have we Learned from Clinical Trials? Ramon L. Varcoe, MBBS, MS, FRACS, PhD Associate Professor of Vascular Surgery University of New South Wales Sydney,
More informationDCB in my practice: How the evidence influences my strategy. Yang-Jin Park
DCB in my practice: How the evidence influences my strategy Yang-Jin Park Associate Professor Division of Vascular Surgery, Department of Surgery Samsung Medical Center Sungkyunkwan University School of
More informationSix Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease
Six Month Results of the Global BIOLUX P-III All-Comers Registry using Drug Coated Balloon in Infra-Inguinal Artery Disease Prof. Dr. Gunnar Tepe, Klinikum Rosenheim, Germany CCI on behalf of the BIOLUX
More informationDrug Elution, Data, and Decisions
Drug Elution, Data, and Decisions What the data tell us about how to integrate drug-eluting technology into our daily practice. BY GARY ANSEL, MD, AND JOHN A. PHILLIPS, MD The use of drug-eluting technology
More informationHybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results.
Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results. Wronski J. 1), 2) 3), Wilczynski M 1), Gembal P 1), Milik K 1), Dec St 1), Grybos
More informationCOMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions. Dierk Scheinert
COMPARE-Pilot RCT: 1-year results of a randomised comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions Dierk Scheinert Department of Angiology University Hospital Leipzig, Germany Disclosure
More informationSustained Release. Superior Results.
ELUVIA Drug-Eluting Vascular Stent System Sustained Release. Superior Results. Superiority determined in Post Hoc Superiority Analysis. 12-Month Primary Patency rate of 86.8% in the Eluvia arm (n=309)
More informationNeuestes aus der Therapie der pavk. beschichtete Stents + Ballons. Karls-University. Eberhard-Karls. of Tubingen Department of Diagnostic Radiology
Eberhard-Karls Karls-University of Tubingen Department of Diagnostic Radiology Neuestes aus der Therapie der pavk Berlin Dezember 08 beschichtete Stents + Ballons Gunnar Tepe 1 Local Drug Delivery Basic
More informationLIBERTY 360 Study. 15-Jun-2018 Data 1. Olinic Dm, et al. Int Angiol. 2018;37:
LIBERTY 360 Study LIBERTY is a prospective, observational, multi-center study to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic
More informationAtherectomy with thrombectomy of. Rotarex S : The Leipzig experience
Atherectomy with thrombectomy of femoropopliteal occlusions with Rotarex S : The Leipzig experience Dr. Bruno Freitas, Prof., MD Department of Interventional Angiology, Universität Leipzig, Germany Santa
More informationMichael K. W. Lichtenberg MD, FESC on behalf of KANSHAS 1 investigators; Tepe G, Müller-Hülsbeck S, Deloose K, Verbist J, Goverde P, Zeller T
Interim 30-day analysis from the KANSHAS 1 study of the novel KANSHAS drug coated balloon for treatment of femoropopliteal occlusive disease; a latest first-in-human study Michael K. W. Lichtenberg MD,
More informationThe present status of selfexpanding. for CLI: Why and when to use. Sean P Lyden MD Cleveland Clinic Cleveland, Ohio
The present status of selfexpanding and balloonexpandable tibial BMS and DES for CLI: Why and when to use Sean P Lyden MD Cleveland Clinic Cleveland, Ohio Disclosure Speaker name: Sean Lyden, MD I have
More informationCombination therapy : treatment rationale and clinical evidence
LINC Asia Pacific 2016, Hong Kong A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist Combination therapy : treatment rationale
More informationMerits and demerits of DES, DEB or covered stent in lower extremity arterial occlusive disease 성균관의과대학삼성서울병원순환기내과최승혁
Merits and demerits of DES, DEB or covered stent in lower extremity arterial occlusive disease 성균관의과대학삼성서울병원순환기내과최승혁 Contents DES in SFA DES in BTK DEB in SFA DEB in BTK Current status of covered stent
More informationAlternative concepts for drug delivery in BTK arteries the LIMBO project
Alternative concepts for drug delivery in BTK arteries the LIMBO project Dierk Scheinert, MD Division of Interventional Angiology University Hospital Leipzig, Germany 1 Disclosure Speaker s name: Dierk
More informationHow do I use mechanical debulking for the treatment of arterial occlusions
How do I use mechanical debulking for the treatment of arterial occlusions Sven Bräunlich, MD Division of Interventional Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Sven Bräunlich
More informationSuperficial Femoral Artery Intervention: The gift that keeps on giving! Wm. Britton Eaves,MD WKHSC Bossier City, LA
: The gift that keeps on giving! Wm. Britton Eaves,MD WKHSC Bossier City, LA Peripheral arterial disease (PAD) of the superficial femoral artery (SFA) is the most common cause of intermittent claudication
More informationAdventitial Drug Infusion to Prevent Restenosis
Adventitial Drug Infusion to Prevent Restenosis Marianne Brodmann, M.D. University of Graz Graz, Austria Disclosure Speaker name: Marianne Brodmann... I have the following potential conflicts of interest
More informationTreatment Strategies for Long Lesions of greater than 20 cm
Treatment Strategies for Long Lesions of greater than 20 cm Donald L. Jacobs, MD C. Rollins Hanlon Professor and Chair Chair of the Department of Surgery Saint Louis University Disclosure Speaker name:
More informationDCB + BMS is not a DES
DCB + BMS is not a DES Fabrizio Fanelli, MD, EBIR Professor of Radiology Director Vascular and Interventional Radiology Department "Careggi " University Hospital Florence - Italy Disclosures Consultant
More informationFinal Results of the Feasibility Study for the Drug-coated Chocolate Touch PTA balloon. (The ENDURE Trial)
Final results of the feasibility study for the drug-coated Chocolate Touch PTA balloon of of femoropopliteal Femoropopliteal lesions lesions: (The ENDURE Trial) Final Results of the Feasibility Study for
More informationISR-treatment The Leipzig experience with purely mechanical debulking. Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany
ISR-treatment The Leipzig experience with purely mechanical debulking Sven Bräunlich Department for Angiology University-Hospital Leipzig, Germany Disclosure Speaker name: Sven Bräunlich I have the following
More informationEndovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial
Endovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial Prof. Thomas Zeller, MD Department Angiology Clinic for Cardiology and Angiology II University Heart-Center
More informationPaclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment
Paclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment HEALTH QUALITY ONTARIO NOVEMBER 2015 Ontario Health Technology Assessment Series; Vol. 15: No. 20, pp. 1 62,
More informationThe Role of Lithotripsy in Solving the Challenges of Vascular Calcium. Thomas Zeller, MD
The Role of Lithotripsy in Solving the Challenges of Vascular Calcium Thomas Zeller, MD 1 1 Disclosure Speaker name: Thomas Zeller... I have the following potential conflicts of interest to report: X X
More informationRobert W. Fincher, DO The Ritz-Carlton, Dove Mountain Marana, Arizona February 7th, 2015
Robert W. Fincher, DO The Ritz-Carlton, Dove Mountain Marana, Arizona February 7th, 2015 Disclosure I have nothing to disclose Randomized Controlled Studies In SFA Technology: What s The Best Tool For
More information2 Year Results from the MDT SFA Japan Trial - DCB vs. standard PTA for the treatment of atherosclerotic lesions in the SFA/PPA
2 Year Results from the MDT- 2113 SFA Japan Trial - DCB vs. standard PTA for the treatment of atherosclerotic lesions in the SFA/PPA Osamu Iida, MD - Kansai Rosai Hospital, Hyogo, Japan Hiroyoshi Yokoi,
More informationPreliminary 6-month results of VMI-CFA trial
Preliminary 6-month results of VMI-CFA trial Koen Deloose, MD Head Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium Disclosure slide Speaker name: Koen Deloose, MD I have the following potential
More informationExcimer Laser angioplasty for femoro-popliteal disease. Sendai Kousei Hospital, Tokyo Kamata Hospital Naoto Inoue MD, FSCAI, FJCC, FAHA
Excimer Laser angioplasty for femoro-popliteal disease Sendai Kousei Hospital, Tokyo Kamata Hospital Naoto Inoue MD, FSCAI, FJCC, FAHA Speaker s name: Naoto Inoue I have the following potential conflicts
More informationStents for Femoropopliteal Disease:
1 TheZilverPTX RandomizedTrial ofpaclitaxel Eluting Stents for Femoropopliteal Disease: 24 Month thupdate Mark kw. Burket, MD M.D. Professor of Medicine Director of Vascular Medicine University of Toledo
More informationDisclosures. In-Stent Restenosis: The Tail IS Wagging the Dog 4/15/2016. Restenosis: The Continuing Challenge for Peripheral Vascular Intervention
In-Stent Restenosis: The Tail IS Wagging the Dog Disclosures NONE Michael S. Conte MD Division of Vascular and Endovascular Surgery UCSF Heart and Vascular Center UCSF Vascular Symposium 2016 IF YOU WERE
More informationUpdate on Tack Optimized Balloon Angioplasty (TOBA) Below the Knee. Marianne Brodmann, MD Medical University Graz Graz, Austria
Update on Tack Optimized Balloon Angioplasty (TOBA) Below the Knee Marianne Brodmann, MD Medical University Graz Graz, Austria Critical Limb Ischemia Infrapopliteal arterial disease is a leading source
More information