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

ID#: NCT06872905

Age: 18 - 100 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: May 30, 2025

End Date: August 16, 2027

Contact Information:
Jennifer Camoriano, BS
14805365820
Chris Timberlake, BS
1-928-707-4974
Summary:

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).

Eligibility:



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. -