NCT04009512

Endovascular Repair of Thoracoabdominal Aortic Aneurysms

Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

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

Summary

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.

Detailed description

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.

Conditions

• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Valiant Thoracoabdominal Stent Graft System	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.

Timeline

• Start date: 2020-10-06
• Primary completion: 2026-08-26
• Completion: 2026-08-26
• First posted: 2019-07-05
• Last updated: 2021-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study