Clinical Trial: Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms

Brief Summary: A prospective, single-arm, traditional feasibility study of a physician-modified fenestrated Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events will also be recorded by the Sponsor-Investigator and will be monitored by a locally appointed Data Monitoring Committee, the Colorado Multiple Institutional Review Board, and the FDA.