Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

Brief Summary

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

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Detailed Description

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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 with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.

Conditions

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Popliteal Artery Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Popliteal aneurysm

GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm

GORE® VIABAHN® Endoprosthesis

Intervention Type DEVICE

Interventions

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GORE® VIABAHN® Endoprosthesis

Intervention Type DEVICE

Other Intervention Names

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Viabahn

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No