Medical device developer Medtronic said it has begun a clinical study evaluating whether early endovascular repair of small abdominal aortic aneurysms (AAA) -- those smaller than 5 cm in diameter that meet certain conditions -- is superior to periodic surveillance.
The Cleveland Clinic is the coordinating center for the Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL) trial, which will use the Minneapolis-based firm's AneuRx abdominal aortic stent-graft system in patients from the treatment group.
The PIVOTAL study is a multicenter prospective randomized trial comparing early stent-graft intervention to medical surveillance, and will enroll nearly 1,700 patients at more than 50 clinical centers. The primary end point is the cumulative occurrence of the composite of rupture or aneurysm-related death within three years, Medtronic said.
By AuntMinnie.com staff writers
July 7, 2005
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