VENOVO Venous Stent Update on the Vernacular Trial

Transcription

1 VENOVO Venous Stent Update on the Vernacular Trial Dr. Sunder Narasimhan, MBBS, MS Senior Consultant Vascular and Endovascular Surgeon Apollo Hospital, Bangalore, India VENOVO is a registered trademark of Becton, Dickenson and Company The VENOVO Venous Stent is limited by US Law to Investigational Use only, and not available for sale or distribution in the U.S.

2 Disclosure Speaker name: Sunder Narasimhan I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 Patient history 55yr old gentleman Craniotomy for IC bleed. Post procedure DVT. IVC filter placed.[non Retreivable]. 1 month later swollen lower limbs both sides, CT venogram thrombotic IVC occlusion. Anticoagulated. Devoloped massive edema with large exudative wound both legs after 6 months

4 Massively swollen lower limb

5 IVC filter thrombus and occlusion

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7 Complete infra filter IVC occlusion

8 Exudative leg ulcers

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20 Post procedure 4days

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22 References

23 References

24 Venous Stent Development: Disease Understanding Identified the need(s) for improvement or new technology to treat venous disease Developed venous loading models through literature review and 3-D volumetric imaging of iliofemoral veins in cadavers Measured loading conditions (bending) from fluoroscopic human images Measured patients with stented veins (ultrasound) during respiratory and valsalva maneuvers to calculate changes in venous diameter.

25 Venous Stent Development: Design Considerations for the Ideal Venous Stent Dedicated stent design Balance between radial force and flexibility High flexibility High radial force High compression resistance Large diameters Long lengths Easy and accurate deployment Easy to deploy Radiopaque Limited foreshortening

26 VENOVO Venous Stent System Manufactured by Becton, Dickenson and Company, Peripheral Interventions, Tempe, Arizona, USA Limited in the US to Investigational Use In India and other regions of the world it is indicated for the treatment of stenoses and occlusions in the iliac and femoral veins Tri-axial delivery system.035 OTW Dual-speed deployment thumbwheel Ergonomic handle Self-expanding nitinol Dedicated design for venous vessels 6 markers at each end (3 nitinol, 3 tantalum) Ends flared 3mm to ensure wall apposition The VENOVO Venous Stent is limited by US Law to Investigational Use only, and not available for sale or distribution in the U.S.

27 VENOVO Venous Stent Design 3 Radiopaque Tantalum Markers Alternates between 3 and 6 Nitinol Connectors in the main body of the stent Connectors 3 Non-radiopaque Nitinol Markers The VENOVO Venous Stent is limited by US Law to Investigational Use only, and is not available for sale or distribution in the U.S.

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29 Stent Lengths Stent Sizes Used in the VERNACULAR Trial 40 mm 60 mm 80 mm 100 mm 120 mm 140 mm 160 mm Stent Diameters 10 mm 12 mm 14 mm 16 mm 18 mm 20 mm 8F 9F 10F The VENOVO Venous Stent is limited by US Law to Investigational Use only, and is not available for sale or distribution in the U.S.

30 VERNACULAR Trial The VENOVO Venous Stent Study - A Prospective, Non- Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease an Assessment for Effectiveness and Safety Design: Prospective, multi-center, single-arm study (non-randomized) of the VENOVO Venous Stent in the treatment of iliofemoral occlusive disease Investigative Sites: Europe, UK, Ireland, Australia, and the US Patients Eligible: Acute or Chronic DVT, May-Thurner Syndrome, or any combination of the above Follow Up: At hospital discharge, and 1-, 6-, 12-, 24-, and 36 months post procedure Independent Core Labs and Safety Committees: Venographic Core Lab: Yale Cardiovascular Research Group Duplex Ultrasound Core Lab: VasCore Clinical Events Committee (CEC) and Date Safety Monitoring Board (DSMB) adjudicated safety events The VENOVO Venous Stent is limited by US Law to Investigational Use only, and is not available for sale or distribution in the U.S.

31 Key Inclusion & Exclusion Criteria Inclusion: Symptomatic (non-malignant) venous outflow obstruction in the iliofemoral venous segment(s) of 50% (with contrast venography). Clinical-Etiology-Anatomic-Pathophysiologic Score CEAP C 3 or a Venous Clinical Severity Score VCSS (pain score) of 2. Reference vessel diameter(s) between 7mm and 19mm Exclusion: Contralateral disease of the iliofemoral venous segments Asymptomatic: CEAP C <3, or a VCSS pain score of <2 Venous obstruction that extended into or below the level of the lesser trochanter Uncorrectable bleeding diathesis or active coagulopathy, or known allergy or sensitivity to Nickel, Titanium, or contrast media Lesions that cannot be crossed with a guidewire, had prior stent in the target vessel, or was unsuitable for treatment with available stent sizes

32 Primary Endpoints Safety: Freedom from Major Adverse Events (MAEs) through 30 days Device and/or procedure related death Major amputation of target limb Pulmonary Embolism which is clinically important (symptomatic with chest pain, hemoptysis, dyspnea, hypoxia, etc.) Target Vessel Revascularization (TVR) Vascular injury requiring surgical/endovascular intervention Embolization/migration of stent Device or procedure related acute DVT involving the treated limb

33 Primary Endpoints Efficacy: Primary Patency rate at 12 months defined as Freedom from TVR Freedom from thrombus, occlusion, and stenosis > 50% as measured by DUS Evaluated against a literature-derived performance goal Note: Venography was used only if the investigator could not successfully measure the endpoint by DUS or if there was a need to perform invasive venography.

34 Key Secondary Endpoints Evaluation of VCSS & CEAP Scores, and QOL through 36 months Acute Technical Success: successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator Acute Procedure Success: technical success with no major adverse events from the time of the treatment to discharge Lesion Success: < 50% residual stenosis Freedom from TVR & TLR through 36 months Primary Patency at 24, 36 months X-ray analysis for stent fracture at 12, 24, and 36 months

35 Investigators & Centers T. Zeller, Universitaets- Herzzentrum Freiburg-Bad Krozingen, Germany M. Lichtenberg, Klinikum Arnsberg, Germany G. O Sullivan, University Hospital Galway, Ireland S. Black, Guy s & St Thomas Hospital, London, UK M.W. de Haan, MUMC Maastricht, The Netherlands L. M. Izquierdo Lamoca, Fundacion de investigación HM Hospitales, Madrid, Spain H. Jalaie, Uniklinik RWTH Aachen, Aachen, Germany S. Dubenec, Royal Prince Alfred Hospital, Camperdown, Australia P. Mwipatayi, JMLS Medical Services PTY LTDT/A PERTH INST. OF VASCULAR RESEARCH, Nedlands, Australia J. Apple, Cardiothoracic and Vascular Surgeons, Texas, USA R. Lookstein, Mount Sinai Medical Center, New York, USA J. Mullins, Cox Medical Centers, Massachusetts, USA D. Dexter, Sentara Norfolk General Hospital and Sentara Careplex Hospital, Virginia, USA N. Shammas, Midwest Cardiovascular Research Foundation, Iowa, USA S. Abu-Halimah, CAMC Health Education and Research Institute, West Virginia, USA B. Ferris, Lake Washington Vascular, PLLC, Washington, USA B.Karenko/F. Saab, Metro Health Hospital, Michigan, USA R. Mendes, NC Heart and Vascular Research, LLC, North Carolina, USA R. Attaran, Yale University Medical Center, Connecticut, USA R. Morford, Centra Health, Inc. dba Stroobants Cardiovascular Center, Virginia, USA P. Gagne, Vascular Breakthroughs, LLC, Connecticut, USA 21 Centers in the Europe, UK, Ireland, Australia, and the US Enrolled 170 Patients

36 VERNACULAR Trial Update As of March 2018 Enrollment: Started June 2016 (Completed) Patients Enrolled: 170 Active Trial Sites: 21 Europe, Ireland, UK: 7 sites (65 patients) Australia: 2 sites (5 patients) United States: 12 sites (100 patients) Follow Up: 12-month data collection ongoing

37 Conclusion IVC filter chronic thrombus and occlusion {2-30%}HANN et all and {2-20%} in Geogiadus study Thrombolysis and filter removal in Acute IVC filter thrombosis. Stent placement to cush filter against the wall in chronic occlusion. Though the venova stent has not been evaluated yet in IVC the product has no contraindication for IVC anatomy Venova stent has high radial force and is the most suitable venous stent for IVC filter occlusion. Further studies needed to establish the role of Venova stent in IVC occlusion.

38 Thank you

39 VENOVO Venous Stent Update on the Vernacular Trial Dr. Sunder Narasimhan, MBBS, MS Senior Consultant Vascular and Endovascular Surgeon Apollo Hospital, Bangalore, India VENOVO is a registered trademark of Becton, Dickenson and Company The VENOVO Venous Stent is limited by US Law to Investigational Use only, and not available for sale or distribution in the U.S.