Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Popliteal aneurysm	GORE® VIABAHN® Endoprosthesis	GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.	12 months following initial study procedure	A composite of freedom from failure of technical success or loss of primary patency at 12 months
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 days following initial study procedure	30 day serious adverse events related to the initial study procedure or the study device.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
The Vascular Group of Naples
🇺🇸
Naples, Florida, United States
Baptist Health
🇺🇸
Miami, Florida, United States