For Physicians
CLINICAL TRIALS FOR COMPLEX THORACIC AORTIC PATHOLOGIES
Despite the initial FDA approval of only one thoracic aortic stent graft device (limited to treatment of degenerative aneurysm) to-date, ongoing and developing clinical trials are needed to define the ultimate role of stent graft repair in the spectrum of thoracic aortic pathology. One of our directors, Richard P. Cambria, MD, serves as national Principal Investigator for the W.L.Gore sponsored trial of stent graft repair for complex thoracic aortic pathology. In this trial, 60 patients with traumatic aortic tear, ruptured degenerative aneurysms, and complicated type B aortic dissections will be treated with stent graft repair and compared to literature based results with conventional open repair. We are currently enrolling patients in this trial with enrollment completion anticipated for late 2006.
A second trial with the Cook,inc. TX2 device, specifically designed for aortic dissection cases, is due to begin in mid 2006 with MGH serving as the only study site in New England. This unique device combines covered stent grafts to seal the entry tear and uncovered distal stents to remold the dissected aorta. We are accepting referrals for stent graft repair of type B dissections.
Finally the role of "hybrid" procedures, which combine an open surgical component and stent grafting, in the treatment of extensive aneurysms that extend either into the arch vessels, and/or the visceral aortic segment is under investigation at the MGH. Preliminary experience suggests that this considerably less morbid procedure can be applied in patients at high risk for conventional surgical repair.
Thoracic Aortic Center Contact
Information
 617-724-4747
Massachusetts General Hospital Thoracic Aortic Center
55 Fruit Street, YAW-5800
Boston, MA 02114
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