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 enrollmentSeptember 2013

ConditionsFemoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Femoral Artery Stenosis
Sponsor: Medtronic Endovascular
Enrollment: 100
Locations: 1
Primary Endpoint: Efficacy: Primary patency
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

April 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

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

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)