Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

W.L. Gore & Associates

Status: Enrolling

Conditions: Aortoiliac Occlusive Disease

Treatments: Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Study type: Observational

Funder types: Industry

Identifiers

NCT06872905

VBX 24-03

Details and patient eligibility

About

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Full description

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
4. Age ≥18 years at the time of CERAB procedure.
5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

Exclusion criteria

1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.

2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).

3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

Trial design

158 participants in 1 patient group

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis

Description:

Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Treatment:

Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)