The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with 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 is to assess the use of the thoracic bifurcation and the visceral manifold stent graft system to repair thoracoabdominal aortic aneurysms in patients with 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
15
This system of devices works to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments in patients with thoracoabdominal aneurysms.
Massachusetts General Hospital
Boston, Massachusetts, United States
Freedom from MAEs (at 30 Days)
Major Adverse Events include: all-cause mortality within 30 days of the procedure, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Time frame: 30 Days post- procedure
Preliminary Effectiveness (treatment and technical success)
Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement i.e., \>5mm as compared to any previous 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 post-procedure
Technical Success
Technical success and the individual components of technical success include: * Successful delivery * Deployment at the intended implantation site * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent covering of aortic branch vessels * Successful withdrawal
Time frame: at each follow-up interval (five years)
Treatment Success
Treatment success and the individual components of treatment success including freedom from the following at each follow-up interval: * Aneurysm enlargement * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events). * Renal failure * All-cause mortality * Endoleaks * Device integrity failure (e.g., fracture) * Patency-related events (i.e., device stenosis or occlusion and embolic events) * Other device-related events
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Time frame: at each follow-up interval (five years)