Atherosclerosis
Conditions
Interventions
Medical device VIABAHN® VBX Balloon Expandable Endoprosthesis
Sponsors
W. L. Gore & Associates, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient treated with CERAB procedure for AIOD. 2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure. 3. Patient was treated with the CERAB index procedure a minimum of 1 year before enrollment date. 4. Age =18 years at the time of the CERAB procedure. 5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC)
Exclusion criteria
Exclusion criteria: 1. Patient with prior stenting in the aortic or common iliac artery at the time of the CERAB procedure. 2. Patient treated with concomitant chimney procedure at time of the 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 |
|---|---|
| Primary Effectiveness Endpoint (hypothesis testing): • 1-Year Primary Patency o Defined as: Blood flow through the target lesion (no evidence of binary restenosis >50%) without a target lesion revascularization (TLR). Primary Safety Endpoint (hypothesis testing): • 30-day Morbidity o Defined as: Any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (descriptive statistics): • Technical Success at index procedure • 30-Day Mortality • Freedom from VBX Stent Graft fracture (Device Integrity Endpoint) through available study follow-up• Primary patency through available study follow-up • Primary assisted patency through available study follow-up • Secondary patency through available study follow-up • Freedom from target lesion revascularization through available study follow-up • Freedom from clinically-driven target lesion revascularization through available study follow-up • Survival through available study follow-up | — |
Countries
Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactE.V. Dolieslager
ICON Clinical Research
Outcome results
None listed