Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Study Overview
=================
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 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.

Official Title
-----------------
Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication

Conditions
-----------------
Popliteal Artery Aneurysm

Intervention / Treatment
-----------------
* Device: GORE® VIABAHN® Endoprosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Popliteal aneurysm<br>GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm | Device: GORE® VIABAHN® Endoprosthesis<br> <br> * Other names: Viabahn;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. | A composite of freedom from failure of technical success or loss of primary patency at 12 months | 12 months following initial study procedure | 
| Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure. | 30 day serious adverse events related to the initial study procedure or the study device. | 30 days following initial study procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
popliteal artery, aneurysm, popliteal artery aneurysm, asymptomatic aneurysm, mural thrombus, Viabahn, Gore, Endoprosthesis