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/NCT01175850

NCT01175850N/ACompleted

Compare CT.gov

Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

Medtronic Endovascular·interventional·Posted Aug 5, 2010·Updated May 16, 2017

In Brief

A clinical study evaluating Drug-Coated Balloon (DCB) and PTA Balloon: Balloon Angioplasty for Peripheral Arterial Disease (PAD). Completed, enrolled 331 participants across 1 site.

Detailed Summary

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPeripheral Arterial Disease (PAD)

CountriesGermany

Collaborators--

Timeline

N/ACompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedAug 2010

Enrollment StartSep 2010

Primary CompletionFeb 2014

Study CompletionApr 2017

TodayJul 2026

First PostedAug 5, 2010

Enrollment StartSep 1, 2010

Primary CompletionFeb 1, 2014

Study CompletionApr 1, 2017

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 15.9 years ago

Interventions

Drug-Coated Balloon (DCB)device

balloon dilatation and provisional stenting with IN.PACT DCB

PTA Balloon: Balloon Angioplastydevice

balloon dilatation and provisional stenting with standard non-coated PTA balloon