MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery

Study Overview
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Brief Summary
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The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).

Official Title
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Randomized Trial of MDT-2113 Drug-Eluting Balloon (DEB) vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery

Conditions
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Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion

Intervention / Treatment
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* Device: MDT-2113 Drug-Eluting Balloon
* Device: Standard angioplasty balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 20 years and ≤ 85 years Documented ischemia with Rutherford classification 2, 3, or 4 Able to walk without assistive devices Target lesion is in the SFA and/or PPA above the knee Target lesion consists of a single de novo or non-stented restenotic lesion (or tandem lesions) or is a combination lesion that meets the following criteria: ≥ 70% and < 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm 100% occluded with total lesion length ≤100 mm Combination lesions must have total lesion length ≥40 mm and ≤200 mm with an occluded segment that is ≤ 100 mm in length (by visual estimates) Reference vessel diameter ≥ 4 mm and ≤7 mm (by visual estimate) Angiographic evidence of adequate distal run-off through the foot Exclusion Criteria: Stroke or STEMI within the 3 months prior to enrollment Either local or systemic thrombolytic therapy within the 48 hours prior to the index procedure Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT) Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies or to paclitaxel, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure Chronic renal insufficiency Subject is enrolled in another investigational device, drug, or biologic study Any major surgical procedure or intervention performed within the 30-day period prior to or post index procedure Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure Failure to successfully cross the target lesion Angiographic evidence of severe calcification Target lesion known in advance of enrollment to require treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, cutting balloons, scoring balloons; use of embolic protection devices is also prohibited

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDT-2113 Drug-Eluting Balloon<br>Paclitaxel drug-eluting angioplasty balloon | Device: MDT-2113 Drug-Eluting Balloon<br>* Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm<br>|
| Active Comparator: Standard angioplasty balloon<br>Standard PTA balloon without Paclitaxel drug-elution | Device: Standard angioplasty balloon<br>* Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Primary patency | Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoint | Freedom from device- and procedure-related death through 30 days post-procedure, and freedom from target limb major amputation and clinically-driven target vessel revascularization (TVR) | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-Eluting Angioplasty Balloon, Drug Coated Angioplasty Balloon, Peripheral Artery Disease, Experimental, Percutaneous Transluminal Angioplasty (PTA)