NCT03075748

Visceral Manifold Study for the Repair of TAAA

Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thoracoabdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	TAAA Debranching Stent Graft System	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.

Timeline

• Start date: 2017-12-19
• Primary completion: 2025-12-01
• Completion: 2027-02-01
• First posted: 2017-03-09
• Last updated: 2025-01-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study