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.
Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
Informed Consent Form (ICF) is signed by subject
Subject is capable of complying with protocol requirements, including follow-up
Life expectancy > 2 years
Mycotic or ruptured aneurysm
ASA class V (moribund patient not expected to live 24 hours with or without operation)
Renal insufficiency defined as creatinine > 1.8 mg/dL or undergoing dialysis
NYHA class IV
Parallel
GORE® EXCLUDER® IBE Plus Stent Graft
DeviceEndovascular 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
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
Freedom From New Onset Buttock Claudication on an IBE Plus-Treated Side
Freedom from new onset buttock claudication on an IBE Plus-treated side
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