Clinical trial NCT06872905: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortoiliac Occlusive Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
timeFrame: 1-Year
measure: Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
timeFrame: 30-Day
Secondary outcomes:
measure: Technical Success
timeFrame: At index procedure
measure: Mortality
timeFrame: 30-Day
measure: Device Integrity
timeFrame: 1 year
measure: Primary assisted patency
timeFrame: 1 year
measure: Secondary patency
timeFrame: 1 year
measure: Freedom from Target Lesion Revascularization
timeFrame: 1 year
measure: Survival
timeFrame: 1 Year
measure: Freedom from Clinically-Driven Target Lesion Revascularization
timeFrame: 1 year
Other outcomes:
Locations:
city: Fresno
country: United States
facility: University of California
state: California
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria di Padova
Study officials:
affiliation: University of California, San Francisco
name: Leigh Ann O'Banion, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero-Universitaria di Padova
name: Michele Antonello, M.D.
role: PRINCIPAL_INVESTIGATOR
References: