Clinical Research Directory

Thoracoabdominal Artery Stent Graft System Exploratory Study

This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Visceral Manifold Study for the Repair of TAAA

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.