Table 2.
Main study entry criteria
| 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 |