post-approval trial of the talent™ abdominal stent graft to treat aortic aneurysms

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the talent abdominal stent graft system, in a post-approval environment.

the talent abdominal stent graft system is a next-generation modular system for endovascular repair of abdominal aortic aneurysm (aaa). the system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies. medtronic vascular submitted a pre-market application (pma) to the food and drug administration (fda) on october 17, 2007, and received market approval for the talent abdominal stent graft system on april 15th, 2008. as a condition of approval, the fda has requested a post-approval study. medtronic has therefore designed a post-approval study, in collaboration with fda, to document the performance of the talent abdominal stent graft system under market conditions.

Eligibility criteria:
inclusion criteria: * subject must have an abdominal aortic aneurysm, with or without iliac involvement. * iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; * a proximal aortic neck length of ≥ 10mm; * proximal aortic neck angulation ≤ 60°; * distal iliac artery fixation length of ≥ 15mm; * an aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and * vessel morphology suitable for endovascular repair. 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.

Keywords: aortic aneurysm aneurysm abdominal aortic aneurysm talent medtronic