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
Phase phase 2
Sponsor Medtronic Endovascular
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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Paclitaxel drug-eluting angioplasty balloon
mdt-2113 drug-eluting balloon
Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
(Active Comparator)
Standard PTA balloon without Paclitaxel drug-elution
standard angioplasty balloon
Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Primary Outcomes

Efficacy: Primary patency
time frame: 12 month

Secondary Outcomes

Primary safety endpoint
time frame: 12 month

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.