Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms

Exclusion Criteria

• •Are less than 18 years of age
• •Are pregnant or lactating
• •Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior mesenteric artery
• •Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the bilateral internal iliac arteries
• •Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent Graft as per the indications in Section 3.
• •Have no distal vascular bed (one vessel lower extremity run-off required)
• •Have contraindications for use of contrast medium or anticoagulation drugs
• •Have an uncorrectable coagulopathy
• •Have an SVS/AAVS score greater than 2
• •Have a mycotic aneurysm
• •Have circumferential mural thrombus in the proximal aortic neck
• •Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or major surgical intervention
• •Have traumatic aortic injury
• •Have leaking, pending rupture or ruptured aneurysms
• •Have pseudoaneurysms resulting from previous graft placement
• •Require a revision to previously placed endovascular stent grafts.
• •Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)
• •Have concomitant thoracic aortic or thoracoabdominal aneurysms
• •Are patients with active systemic infections
• •Are patients who have a condition that threatens to infect the graft.
• •Are patients with sensitivities or allergies to the device materials.
• •Have access vessels (as determined by treating physician) that preclude safe insertion of the delivery system. NOTE: Iliac conduits may be used to ensure the safe insertion of the delivery system.