CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 358 enrolled
Drug / intervention
IN.PACT Amphirion +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/NCT00941733
NCT00941733N/ACompleted
CompareCT.gov

Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia

Medtronic Endovascular·interventional·Posted Jul 20, 2009·Updated Feb 28, 2018

In Brief

A clinical study evaluating IN.PACT Amphirion and Standard PTA for Critical Lower Limb Ischemia. Completed, enrolled 358 participants across 13 sites in 6 countries.

Detailed Summary

This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Lower Limb Ischemia
CountriesAustria, Belgium, Germany, Italy, Netherlands, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2013
Study CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.9 years ago

Interventions

IN.PACT Amphiriondevice

Balloon Angioplasty

Standard PTAdevice

Balloon Angioplasty