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

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

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).

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