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
Purpose
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).
Condition
- Aortoiliac Occlusive Disease
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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. -
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| GORE VIABAHN® VBX Balloon Expandable Endoprosthesis | Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Lori Michalowski
Lori Michalowski
More Details
- Status
- Recruiting
- Sponsor
- W.L.Gore & Associates
Detailed 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.