The Pivotal Study of the Aptus Endovascular AAA Repair System

The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Inclusion criteria

• Infrarenal AAA with a maximum diameter ≥ 4.5 cm.
• Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.
• Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.
• Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.
• Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.
• Bilateral iliac artery distal fixation sites ≥ 10 mm in length.
• Bilateral iliac arteries with an internal diameter between 9 and 20 mm.
• Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.

Exclusion criteria

• Myocardial infarction within past 10 weeks.
• Active systemic infection.
• Ruptured or leaking AAA.
• Mycotic or inflammatory AAA.
• Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).
• Concomitant TAA or thoracoabdominal aortic aneurysms.
• Requires emergent AAA surgery.
• Previous AAA repair.
• Patients with a body habitus that would prevent imaging required by the study.
• Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.
• Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.
• Dialysis dependent renal failure or creatinine > 2.5 mg/dL.
• Allergy to or intolerance of radiopaque contrast agents.
• Patients with a known sensitivity or allergy to implant materials.
• Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.
• Patients with history of bleeding diathesis or hypercoagulable condition.
• Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.
• Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.