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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

NCT number NCT01327950
Study type Observational
Source Endovascular Consultoria Limitada
Contact
Status Completed
Phase N/A
Start date October 2010
Completion date November 2013

See also
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Completed NCT01336101 - Evaluation of Efficacy of the EPICâ„¢ Self-Expanding Nitinol Vascular Stent N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A