Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE VIABAHN® VBX Balloon Expandable Endoprosthesis | Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) | Device | Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) | Proportion of patients maintaining primary patency at 1 Year | 1-Year |
| Primary Safety Endpoint: 30-day Morbidity (hypothesis testing) | Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention. | 30-Day |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Proportion of patients with technical success | At index procedure |
| Mortality | Proportion of patients with all cause death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
-
Not provided
Not provided
As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population.
Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia.
According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Camoriano, BS | Contact | 14805365820 | jcamoria@wlgore.com | |
| Chris Timberlake, BS | Contact | 1-928-707-4974 | ctimberl@wlgore.com |
| Name | Affiliation | Role |
|---|---|---|
| Leigh Ann O'Banion, M.D. | University of California, San Francisco | Principal Investigator |
| Michele Antonello, M.D. | Azienda Ospedaliero-Universitaria di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | Fresno | California | 93721 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30-Day |
| Device Integrity | Proportion of patients achieving Primary Patency | 1 year |
| Primary assisted patency | Proportion of patients achieving Primary Assisted patency | 1 year |
| Secondary patency | Proportion of patients achieving Secondary Patency | 1 year |
| Freedom from Target Lesion Revascularization | Proportion of patients achieving freedom from Target Lesion Revascularization | 1 year |
| Survival | Proportion of patients survival | 1 Year |
| Freedom from Clinically-Driven Target Lesion Revascularization | Proportion of patients achieving freedom from Clinically-Driven Target Revascularization | 1 year |
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
|
| Rutgers | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| Research Foundation SUNY Buffalo | Recruiting | Buffalo | New York | 14203 | United States |
|
| Mount Sinai Medical Center | Recruiting | New York | New York | 10029 | United States |
|
| Research Foundation at SUNY Syracuse | Recruiting | Syracuse | New York | 13210 | United States |
|
| Atrium Health Sanger Heart & Vascular Institute | Recruiting | Charlotte | North Carolina | 28203 | United States |
|
| Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Geisinger Medical Center | Recruiting | Danville | Pennsylvania | 17822 | United States |
|
| University Of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Sanford Clinical Vascular Associates | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| Wellmont Holston Valley Medical Center | Recruiting | Kingsport | Tennessee | 37760 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| The University of Texas Austin | Recruiting | Austin | Texas | 78712 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
|
| Carilion Clinic | Recruiting | Roanoke | Virginia | 24016 | United States |
|
| Marshfield Hospital | Recruiting | Marshfield | Wisconsin | 54449 | United States |
|
| Marshfield Medical Center - Marshfield | Recruiting | Marshfield | Wisconsin | 54449 | United States |
|
| Azienda Ospedaliero-Universitaria di Padova | Not yet recruiting | Padova | 35131 | Italy |
| Ospedale di Circolo e Fondazione Macchi | Recruiting | Varese | 21100 | Italy |
|
| Amsterdam UMC Research BV | Recruiting | Amsterdam | 1105 | Netherlands |
|
| Franciscus | Recruiting | Rotterdam | 3045 PM | Netherlands |
|
| Hospital General Universitario de Alicante | Recruiting | Alicante | 03010 | Spain |
|
| Greater Glasgow Health Board | Recruiting | Glasgow | G12 OXH | United Kingdom |
|