Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)

W.L. Gore & Associates

Status: Completed

Conditions: Popliteal Artery Aneurysm

Treatments: Device: GORE® VIABAHN® Endoprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT02462876

FPR14-03

Details and patient eligibility

About

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion to the study requires the patient:

1. Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
2. Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (< 2 cm) in the popliteal artery;
3. Was 18 years of age or older at the time of the treatment;
4. Had an elective popliteal artery aneurysm procedure;
5. Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Exclusion criteria

Prior to or at the time of implant the patient is / has:

1. Bilateral popliteal artery aneurysms with initial treatment on the same day;
2. Thrombotic occlusion of the popliteal artery or PAA;
3. Marfan syndrome or Ehlers-Danlos syndrome;
4. Unable to tolerate antiplatelet therapy;
5. Thrombophilia requiring long term anticoagulation;
6. Known allergies to the GORE® VIABAHN® Endoprosthesis components;
7. Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.

Trial design