life study: least invasive fast-track evar

Conditions: Abdominal Aortic Aneurysm

Summary: the primary objectives of the life study are to demonstrate the clinical and cost benefits associated with using the ovation® abdominal stent graft platform under the least invasive conditions defined in the fast-track evar protocol. the key elements of the fast-track evar protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no icu admission post procedure, and next day discharge.

the life study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14f) ovation abdominal stent graft platform when using in the percutaneous endovascular aneurysm repair (p-evar) treatment of patients with aaa using a fast-track evar protocol. 250 study patients will be enrolled at up to 40 institutions. follow-up period is one month.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years of age. * patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study). * patient has signed an irb approved informed consent form. * patient is considered by the treating physician to be a candidate for elective open surgical repair of the aaa. * patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following: abdominal aortic aneurysm \>5.0 cm in diameter, aneurysm has increased in size by 0.5 cm in last 6 months, or maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. * patient has suitable anatomy that allows use of the trivascular ovation® abdominal stent graft platform. * patient has suitable femoral arteries at the percutaneous access site that allow use of the perclose proglide suture-mediated closure system via the pre-close technique. * patient must be willing to comply with all required follow-up exams. exclusion criteria: * patient has a need for emergent surgery. * patient has a dissecting aneurysm. * patient has an acutely ruptured aneurysm. * patient has an acute vascular injury. * patient has had a previous repair of the abdominal aortic aneurysm or the iliac artery. * patient has a mycotic aneurysm or has an active systemic infection. * patient has unstable angina. * patient has unstable peripheral artery disease with critical limb ischemia. * patient has congestive heart failure. * patient has had a myocardial infarction and/or stroke within the past 3 months. * patient requires use of techniques that would cover the renal arteries. * patient requires planned adjunctive devices to complete the procedure. * patient has a major surgical or interventional procedure planned during or within ±30 days of the aaa repair. * patient has history of connective tissue disease. * patient has history of bleeding disorders or refuses blood transfusions. * patient has dialysis dependent renal failure or baseline serum creatinine level \>2.0mg/dl. * patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. * patient has a known allergy or intolerance to polytetrafluoroethylene (ptfe), peg-based polymers, fluorinated ethylene propylene (fep) or nitinol. * patient is on home oxygen. * patient is morbidly obese (bmi ≥40 kg/m2). * patient was admitted from a skilled nursing facility. * patient has a limited life expectancy of less than 1 year. * patient has an inability to be discharged within 1 day of the procedure. * patient is currently participating in an investigational device or drug clinical trial. * patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Keywords: abdominal aortic aneurysm