The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Freedom from Major Adverse Events (MAE) at 30 days
Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke
Time frame: 30 days
Proportion of study subjects with treatment success at 1 year
Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement \[i.e., \>5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements\] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Time frame: 1 year
Technical success
Technical success is defined as: * Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location, * Patency of all endovascular graft and branch stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent covering of aortic branch vessels * Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)
Time frame: 1 year
Quality of Life measures
Questionnaire using SF - 36™ Health Survey
Time frame: 30 days, 6 months; 1, 2, 3, 4 and 5 years
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