Visceral Manifold Study for the Repair of TAAA

Thoracoabdominal Aortic Aneurysms Clinical Trial

Official title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Thoracoabdominal Aortic Aneurysms

• NCT number: NCT03075748
• Study type: Interventional
• Source: University of South Florida
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2017
• Completion date: April 2024