MedTrace Logo

Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

NCT00941733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2018-02-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Critical Lower Limb Ischemia

Interventions

DEVICE

IN.PACT Amphirion

Balloon Angioplasty

DEVICE

Standard PTA

Balloon Angioplasty

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Dierk Scheinert, MD · Heart Center Leipzig - University Hospital

  • Thomas Zeller, MD · University Heart Center Freiburg - Bad Krozingen

  • Iris Baumgartner, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-08-31
Completion
2017-11-30

Countries

  • Austria
  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

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 NCT00941733 on ClinicalTrials.gov