MDT‐2113 SFA.

Trial name or 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
Methods	Randomized controlled trial
Participants	Country: Japan Setting: single hospital Number of participants: 100 Inclusion criteria: Age: ≥ 20 to ≤ 85 years Documented ischemia with Rutherford classification 2, 3, or 4 Able to walk without assistive devices Target lesion is in the SFA or the PA (or both) above the knee Target lesion consists of a single de novo or nonstented 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 runoff through the foot Exclusion criteria: Stroke or STEMI within the 3 months prior to enrolment 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 Known allergies or sensitivities to heparin, acetylsalicylic acid (aspirin), other anticoagulant/antiplatelet therapies or to paclitaxel, or an allergy to contrast media that cannot be adequately pretreated prior to the index procedure Chronic renal insufficiency Person 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/proximal PA 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 enrolment 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
Interventions	Uncoated balloon angioplasty device: unspecified DEB device: MDT‐2113 drug‐eluting balloon catheter Drug used: paclitaxel Vessels treated: femoropopliteal arteries
Outcomes	Primary: Freedom from clinically driven TLR and freedom from restenosis as determined by duplex ultrasound Secondary: Freedom from device‐ and procedure‐related death through 30 days postprocedure, and freedom from target limb major amputation and clinically driven TVR
Starting date	September 2013
Contact information	Unspecified
Notes	Sponsor: Medtronic Endovascular