Main inclusion criteria |
− Age ≥ 18 years |
− Male or non-pregnant female |
− Candidate for elective open surgical AAA repair |
− AAA >5.0 cm diameter, increased ≥ 0.5 cm diameter in last 6 months, or maximum diameter > 1.5x adjacent non-aneurysmal aorta |
− Suitable anatomy for endovascular repair with the Ovation Prime Stent Graft |
− Suitable anatomy to allow Perclose ProGlide Suture-Mediated Closure System via the pre-close technique |
Main exclusion criteria |
− Dissecting or acutely ruptured AAA |
− Acute vascular injury |
− Prior AAA or iliac artery repair |
− Mycotic AAA or active systemic infection |
− Unstable angina |
− Unstable peripheral artery disease with critical limb ischemia |
− Congestive heart failure |
− Myocardial infarction or stroke within the past 3 months |
− Need for renal artery coverage (e.g. Chimney graft) |
− Planned adjunctive devices (e.g. renal stent) |
− Major surgery or interventional procedure within the past 30 days |
− Connective tissue disease (e.g. Marfan’s or Ehler’s–Danlos syndrome) |
− History of bleeding disorder or refuses blood transfusions |
− Dialysis-dependent renal failure or serum creatinine >2.0 mg/dl |
− Morbid obesity (BMI ≥40 kg/m2) |
− Home oxygen use |
− Patient admitted from skilled nursing facility |
− Life expectancy < 1 year |
− Anticipated inability to discharge patient within 1 day |
− Participation in investigational device or drug clinical trial |
− Intolerance/hypersensitivity to anticoagulation, contrast media, or stent graft components |