LUTONIX AV Clinical Trial
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1 LUTONIX AV Clinical Trial A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing LUTONIX 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae CL AV IDE Protocol Scott O. Trerotola, MD Stanley Baum Professor of Radiology Professor of Surgery Associate Chair and Chief, Vascular and Interventional Radiology Vice Chair for Quality Perelman School of Medicine of the University of Pennsylvania
2 Disclosures/Disclaimers The speaker s presentation today is on behalf of C. R. Bard/LUTONIX, Inc. The physician has been compensated by Lutonix for the time and effort to present this information. Please consult Bard product labels and inserts relevant to your geography for indications, contraindications, hazards, warnings, cautions, and instructions for use. The opinions and clinical experiences presented herein are for informational and educational purposes only. The results presented may not be predictive for all studies and patients. Results may vary depending on a variety of experimental and clinical parameters. Individual results may vary depending on a variety of patient specific attributes.
3 Conflicts of Interest Paid consultant for the following companies: Bard Peripheral Vascular LUTONIX WL Gore B Braun Teleflex MedComp Cook Royalties Cook Teleflex
4 Agenda Fistula history and dysfunction LUTONIX 035 AV Catheter Trial Trial design 8 month IDE results Summary Bard Owned Image: Illustration by Mike Austin
5 No Major Novel Therapeutic Interventions for Hemodialysis Access in Decades 1 51 Years 1 Vazquez-Padron and Allon New Insights into Dialysis Vascular Access: Impact of Preexisting Arterial and Venous Pathology on AVF and AVG Outcomes Clin J Am Soc Nephrol 11: , doi: /CJN
6 The Impact of ESRD & Access Dysfunction
7 LUTONIX AV Clinical Trial Design
8 LUTONIX AV IDE Clinical Trial Study Design Objective Number of patients/sites Prospective, Global, Multicenter, Randomized, Safety and Effectiveness To assess the safety and effectiveness of the LUTONIX 035 AV Drug Coated Balloon PTA Catheter in the treatment of dysfunctional AV fistulae 285 randomized subjects at 23 clinical sites Primary Effectiveness Endpoint Target Lesion Primary Patency (TLPP) - 6 months Primary Safety Endpoint Follow Up Status Freedom from any serious adverse event(s) involving the AV access circuit through 30 days 1, 3, 6, 9, 12, 18, 24 month visits First Subject: June 2015 Enrollment Completion: March 2016
9 Key Inclusion Criteria CLINICAL CRITERIA Male or non-pregnant female 21 years old Upper extremity AV Fistula w/clinical, physiological, or hemodynamic abnormality ANGIOGRAPHIC CRITERIA Length 10 cm 50% stenosis Successful pre-dilation Diameter 4-12 mm Fistula created >30 days 1+ hemodialysis session 2 needles Catheter removed > 30 days
10 Key Exclusion Criteria CLINICAL CRITERIA ANGIOGRAPHIC CRITERIA Lower extremity access Central veins Thrombosed access >2 lesions in circuit Secondary non-target lesions that cannot be successfully treated Central veins as a secondary lesion, which is clinically significant Bare or covered stent in target or secondary non-target lesions
11 LUTONIX AV Inclusion Criteria Axillosubclavian Junction Fistula Anastomosis Bard Owned Image: Illustration by Paul Schiffmacher
12 Study Design
13 Study Device Offering.035 guidewire compatible, nylon, semi-compliant balloon Over the wire, co-axial shaft, 75 cm Diameter (mm) Balloon lengths (mm) Nominal (atm) RBP (atm) Sheath Profile F F F F F F F F G71274 Rev 0
14 LUTONIX AV Clinical Trial Demographic Data
15 Demographics: LUTONIX AV Clinical Trial Baseline Characteristics Variable LUTONIX DCB (N=141) Control (N=144) Age Male, n (%) 61.7% 59.0% Hypertension, n (%) 94.3% 98.6% Diabetes mellitus, n (%) 58.2% 65.3% Dyslipidemia, n (%) 60.3% 58.3% Current smoking, n (%) 13.5% 14.6% Peripheral arterial disease, n (%) 9.9% 18.1% Coronary heart disease, n (%) 30.5% 27.8%
16 Fistula Locations: LUTONIX AV Clinical Trial Upper arm DCB: 61.7% vs. PTA: 73.4% Antecubital fossa DCB: 5.0% vs. PTA: 4.9% Forearm DCB: 33.3% vs. PTA: 21.7% *Transposed and non-transposed in each location Bard Owned Image: Illustration by Paul Schiffmacher
17 Target Lesion Locations LUTONIX AV Clinical Trial DCB (n=141) PTA (n=144) Anastomotic (%) 4.3% 3.5% Cephalic arch (%) 18.7% 22.5% Cannulation zone (%) 4.3% 9.9% Inflow (%) 33.8% 29.6% Outflow (%) 24.5% 22.5% Swing point (%) 14.4% 12.0% Bard Owned Image: Illustration by Paul Schiffmacher
18 Vessel Locations: LUTONIX AV Clinical Trial DCB (n=141) PTA (n=144) Subclavian vein (%) 0.7% 0.0% Brachial vein (%) 0.7% 0.7% Cephalic vein (%) 68.8% 67.4% Basilic vein (%) 25.5% 28.5% Median cubital vein (%) 1.4% 0.7% Other (%) 2.8% 2.8% Bard Owned Image: Illustration by Paul Schiffmacher
19 Lesion Characteristics: LUTONIX AV Clinical Trial DCB (N=141) PTA (N=144) De novo (%) 30.5% 27.1% Tandem (%) 2.8% 7.0% Mean target lesion length, mm (±SD) 28.4 ± ± 18.69
20 LUTONIX AV Clinical Trial First Look Results: Safety
21 Lutonix AV Clinical Trial Primary Safety at 240 Days LTX DCB (N=141) Standard PTA (N=144) P-value 240 Day Event Free Rate (SE) 48.8% (4.4%) 43.0% (4.2%) 95% CI (39.9%, 57.1%) (34.7%, 51.1%) 95% CI of the rate and the rate difference at each time point were calculated based on normal approximation and one-sided p-value is from test for non-inferiority, with 10% as non-inferiority margin.. Data shown is interim, site reported and subject to change
22 LUTONIX AV IDE Clinical Trial Summary First in Fistula trial designed to incorporate a wide variety of lesion locations/fistula types 8 month results o Safety outcomes are non-inferior to PTA o Patency results tomorrow from 15:36-15:41: Room 1, Main Arena 1 Ongoing clinical trial until all subjects reach 24 months LUTONIX Global AV Registry now recruiting
23 Thank You
24 LUTONIX AV Clinical Trial A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing LUTONIX 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae CL AV IDE Protocol Scott O. Trerotola, MD Stanley Baum Professor of Radiology Professor of Surgery Associate Chair and Chief, Vascular and Interventional Radiology Vice Chair for Quality Perelman School of Medicine of the University of Pennsylvania
Lutonix AV Clinical Trial
Lutonix AV Clinical Trial Long Term Effects of LUTONIX 035 DCB Catheter 18 month Interim Results Scott O. Trerotola, MD Stanley Baum Professor of Radiology Professor of Surgery Associate Chair and Chief,
Lutonix AV Clinical Trial
Long Term Effects of LUTONIX 035 DCB Catheter Interim 24 Month Results Scott O. Trerotola, MD, for the Lutonix AV Investigators Stanley Baum Professor of Radiology Professor of Radiology in Surgery Associate
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Disclosures. Consultant/Independent Contractor: B Braun, Teleflex, MedComp, Cook, Bard, WL Gore Royalty: Cook, Teleflex
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