NCT01947478CompletedNot Applicable
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
Medtronic Endovascular1 site in 1 country100 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy: Primary patency
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard angioplasty balloon
Active Comparator
Standard PTA balloon without Paclitaxel drug-elution
Intervention: Standard angioplasty balloon (Device)
MDT-2113 Drug-Eluting Balloon
Experimental
Paclitaxel drug-eluting angioplasty balloon
Intervention: MDT-2113 Drug-Eluting Balloon (Device)
Outcomes
Primary Outcomes
Efficacy: Primary patency
Time Frame: 12 month
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS)
Secondary Outcomes
- Primary safety endpoint(12 month)
Investigators
Study Sites (1)
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