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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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