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

NCT01947478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-31

No results posted yet for this study

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).

Conditions

  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion

Interventions

DEVICE

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

DEVICE

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

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Osamu Iida, MD · Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01947478 on ClinicalTrials.gov