The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.
The goal of this clinical trial is to evaluate the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft for endovascular revascularization in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease requiring intervention. The study population includes adults aged 22 years and older, both male and infertile female, who meet specific anatomical criteria. The main questions it aims to answer are: Does the IBE Plus Stent Graft provide clinical benefit and maintain safety? Does the device maintain effectiveness? Researchers will evaluate two parallel study arms: * Primary Arm: Subjects with AIAA/CIAA pathology, including a subset newly eligible for treatment with IBE Plus. * Secondary Arm: Subjects requiring EVAR revision for previously treated AIAA/CIAA. Participants will: * Undergo pre-procedure assessments (informed consent, physical exam, lab tests, and CTA imaging). * Receive endovascular treatment with the IBE Plus Stent Graft. * Attend follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-procedure for physical exams, lab tests, and imaging. * Be monitored for adverse events, device performance, and need for reintervention.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft
Freedom From Composite of the Following: All-Cause Mortality, Serious Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Function Decline, Conversion to Open Surgical Repair
Freedom from composite of any of the following events: * All-cause mortality * Serious stroke * Myocardial infarction * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Paraplegia (grade 3) * Respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline resulting in \>50% reduction in baseline eGFR or new-onset dialysis * Conversion to open surgical repair
Time frame: Through 30 days post-treatment
Freedom From Composite of the Following: IBE Plus-Related Reinterventions Involving Type Ib / Ic or Type III Endoleak, Total Occlusion of Any IBE Plus Component, Loss of Primary Patency of the Internal Iliac Device Component
Composite of the following events: * IBE Plus-related reinterventions involving Type Ib / Ic or Type III endoleak * Total occlusion of any IBE Plus component * Loss of primary patency of the internal iliac device component
Time frame: Through the 6 month follow-up visit
Freedom From New Onset Buttock Claudication on an IBE Plus-Treated Side
Freedom from new onset buttock claudication on an IBE Plus-treated side
Time frame: Through the 6 month follow-up visit
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