NCT01412463

DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions

DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	stent placement	* pre-dilation of the study lesion is mandatory * stent placement with 1 Protégé Everflex+ stent * only 1 stent is allowed within the study protocol * post-dilation may be performed but is not mandatory

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-08-09
• Last updated: 2013-10-01

Locations

3 sites across 1 country: Belgium