Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm (PAA 12-01)

W.L. Gore & Associates

Status

Terminated

Conditions

Popliteal Artery Aneurysm

Treatments

Device: GORE® VIABAHN® Endoprosthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT01902888

PAA 12-01

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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