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

Superficial Femoral Artery Stenosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Atherosclerosis
  • Atherosclerosis of Femoral Artery
  • Superficial Femoral Artery Stenosis
Clinical Trial Details
NCT number NCT01327950
Study type Observational
Source Endovascular Consultoria Limitada
Contact
Status Completed
Phase N/A
Start date October 2010
Completion date November 2013
View Details
See also
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