Status:

TERMINATED

Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Lead Sponsor:

W.L.Gore & Associates

Conditions:

Popliteal Artery Aneurysm

Eligibility:

All Genders

18+ years

Brief Summary

This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).

Detailed Description

The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects ...

Eligibility Criteria

Inclusion

  • Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;
  • Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;
  • Was 18 years of age or older; and
  • Had an elective popliteal artery aneurysm procedure.

Exclusion

  • Bilateral popliteal artery aneurysms with initial treatment on the same day
  • Had previous surgery for the popliteal artery aneurysm in the study limb

Key Trial Info

Start Date :

July 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2014

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT01902888

Start Date

July 1 2013

End Date

April 1 2014

Last Update

June 19 2015

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Baptist Health

Miami, Florida, United States

2

The Vascular Group of Naples

Naples, Florida, United States

3

Washington University School of Medicine

St Louis, Missouri, United States