The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
The primary objective of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year). Additionally, the study will assess technical success and treatment success at each follow-up interval.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system
Unitary Manifold Endovascular stent graft system
Unnamed facility
Sioux Falls, South Dakota, United States
Freedom from major adverse events (MAEs) at 30 days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Time frame: 30 days
Treatment success and technical success at 1 year
Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure , and patency-related events
Time frame: 1 year
Treatment success at various timepoints
Treatment success and the individual components of treatment success including freedom from the following: * Aneurysm enlargement * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for migration, type I and III endoleaks, device integrity failure, and patency-related events. * Renal failure * All-cause mortality * Endoleaks * Device integrity failure * Patency-related events * Other device-related events
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
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