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

Not Applicable

Completed

• Conditions: Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion
• Interventions: Device: MDT-2113 Drug-Eluting Balloon; Device: Standard angioplasty balloon

• Registration Number: NCT01947478
• Lead Sponsor: Medtronic Endovascular

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-20
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDT-2113 Drug-Eluting Balloon	MDT-2113 Drug-Eluting Balloon	Paclitaxel drug-eluting angioplasty balloon
Standard angioplasty balloon	Standard angioplasty balloon	Standard PTA balloon without Paclitaxel drug-elution

Primary Outcome Measures

Name	Time	Method
Efficacy: Primary patency	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 Outcome Measures

Name	Time	Method
Primary safety endpoint	12 month	Freedom from device- and procedure-related death through 30 days post-procedure, and freedom from target limb major amputation and clinically-driven target vessel revascularization (TVR)

Trial Locations

Locations (1)

Kansai Rosai Hospital; 🇯🇵 Amagasaki, Hyogo, Japan