The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A total of 15 patients will be enrolled in the study. * 10 subjects total will be treated in the primary study arm * 5 subjects total will be treated in the expanded selection arm The duration of the Investigation is anticipated as follows: * Time to Complete Enrollment: 24 months * Subject Follow-up Time: 5 years from last subject enrollment * Total Duration Time: 7 years The primary objective of the clinical investigation "Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms" is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety acutely (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device acutely (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
The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
Tampa General Hospital/ University of South Florida
Tampa, Florida, United States
University of South Florida - South Tampa Campus
Tampa, Florida, United States
Proportion of subjects free from major adverse events
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
Time frame: 30 days
Proportion of subjects with treatment success
Primary effectiveness outcome: 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: at 1 year
Proportion of subjects with technical success
Time frame: 5 years
Proportion of subjects free from individual components of primary safety endpoint
Individual components of primary safety endpoint include: death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke
Time frame: at 30 days
Proportion of subjects free from paraparesis
Free from paraparesis
Time frame: 30 days
Proportion of subjects with treatment success
Treatment success includes freedom from: 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
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.