NCT01630070

Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries

A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Self-expandable drug eluting stent	Self-Expanding Paclitaxel-Eluting stent

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2012-06-28
• Last updated: 2015-03-09

Locations

5 sites across 1 country: Belgium