Aortoiliac Occlusive Disease
Conditions
Brief 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).
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.
Interventions
DEVICEGORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) | 1-Year | Proportion of patients maintaining primary patency at 1 Year |
| Primary Safety Endpoint: 30-day Morbidity (hypothesis testing) | 30-Day | Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | At index procedure | Proportion of patients with technical success |
| Mortality | 30-Day | Proportion of patients with all cause death |
| Device Integrity | 1 year | Proportion of patients achieving Primary Patency |
| Primary assisted patency | 1 year | Proportion of patients achieving Primary Assisted patency |
| Secondary patency | 1 year | Proportion of patients achieving Secondary Patency |
| Freedom from Target Lesion Revascularization | 1 year | Proportion of patients achieving freedom from Target Lesion Revascularization |
| Survival | 1 Year | Proportion of patients survival |
| Freedom from Clinically-Driven Target Lesion Revascularization | 1 year | Proportion of patients achieving freedom from Clinically-Driven Target Revascularization |
Countries
Italy, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTJennifer Camoriano, BS
CONTACTChris Timberlake, BS
PRINCIPAL_INVESTIGATORLeigh Ann O'Banion, M.D.
University of California, San Francisco
PRINCIPAL_INVESTIGATORMichele Antonello, M.D.
Azienda Ospedaliero-Universitaria di Padova
Outcome results
None listed