CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 331 enrolled
Drug / intervention
Drug-Coated Balloon (DCB) +1 moredevice
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/NCT01566461
NCT01566461N/ACompleted
CompareCT.gov

Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)

Medtronic Endovascular·interventional·Posted Mar 29, 2012·Updated Feb 12, 2019

In Brief

A clinical study evaluating Drug-Coated Balloon (DCB) and PTA Balloon: Balloon Angioplasty for Femoral Artery Stenosis and 3 related conditions. Completed, enrolled 331 participants across 2 sites.

Detailed Summary

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartMar 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.3 years ago

Interventions

Drug-Coated Balloon (DCB)device

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

PTA Balloon: Balloon Angioplastydevice

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm