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Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries

NCT01412541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2020-05-12

Study results available
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Summary

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

Conditions

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

Interventions

PROCEDURE

Standard Uncoated Angioplasty Balloon

Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

DEVICE

Moxy Drug Coated Balloon

Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Kenneth Rosenfield, MD · Massachusetts General Hospital

  • Prof. Dierk Scheinert · University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-11-30
Completion
2018-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Germany

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 NCT01412541 on ClinicalTrials.gov