CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 532 enrolled
Drug / intervention
Standard Uncoated Angioplasty Balloon +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01412541
NCT01412541N/ACompleted
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A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

C. R. Bard·interventional·Posted Aug 9, 2011·Updated May 12, 2020

In Brief

A clinical study evaluating Standard Uncoated Angioplasty Balloon and Moxy Drug Coated Balloon for Femoral Artery Stenosis and 3 related conditions. Completed, enrolled 532 participants across 54 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
CountriesAustria, Belgium, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartJul 1, 2011
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.9 years ago

Interventions

Standard Uncoated Angioplasty Balloonprocedure

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

Moxy Drug Coated Balloondevice

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