NCT00941733

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	IN.PACT Amphirion	Balloon Angioplasty
DEVICE	Standard PTA	Balloon Angioplasty

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-08-01
• Completion: 2017-11-30
• First posted: 2009-07-20
• Last updated: 2018-02-28
• Results posted: 2014-10-27

Locations

13 sites across 6 countries: Austria, Belgium, Germany, Italy, Netherlands, Switzerland