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

NCT01327950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2014-01-30

No results posted yet for this study

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Angiolog Consultoria Ltda

    collaborator UNKNOWN

  • Endovascular Consultoria Limitada

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-07-31
Completion
2013-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327950 on ClinicalTrials.gov