NCT02294435

Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Sanford Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having 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 of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary stent graft system to repair thoracoabdominal aortic aneurysms in patients having 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 Aneurysms

Interventions

Type	Name	Description
DEVICE	Visceral Manifold and Thoracic Bifurcation	Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system
DEVICE	Unitary Manifold	Unitary Manifold Endovascular stent graft system

Timeline

• Start date: 2015-02-01
• Primary completion: 2024-01-31
• Completion: 2029-12-01
• First posted: 2014-11-19
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study