MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
This trial is active, not recruiting.
|Conditions||femoral artery stenosis, popliteal artery stenosis, femoral artery occlusion, popliteal artery occlusion|
|Treatments||mdt-2113 drug-eluting balloon, standard angioplasty balloon|
|Start date||September 2013|
|End date||April 2018|
|Trial size||100 participants|
|Trial identifier||NCT01947478, 10102118DOC|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Efficacy: Primary patency
time frame: 12 month
Primary safety endpoint
time frame: 12 month
Male or female participants from 20 years up to 85 years old.
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: 1. ≥ 70% and < 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm 2. 100% occluded with total lesion length ≤100 mm 3. 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
|Official title||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|
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