NCT01327950

Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions

EPIC SFA - Physician Initiated Trial Investigating the Efficacy of the EPICTM Nitinol Vascular Stent System (Boston Scientific) in Superficial Femoral Lesions: A Prospective, Multi-center Non- Randomized Study - Endoconsul 003

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Endovascular Consultoria Limitada · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions. A total of 100 patients will be included in approximately 10 sites. The study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non- inferior to the published patency rates found in the literature. This non-inferiority will be established by proving that the true rate for the EPICTM Nitinol Vascular Stent System is higher than 82% minus a 10% delta.

Conditions

• Superficial Femoral Artery Stenosis
• Atherosclerosis of Femoral Artery

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-07-01
• Completion: 2013-11-01
• First posted: 2011-04-04
• Last updated: 2014-01-30

Locations

6 sites across 1 country: Brazil