Endovascular Repair of Thoracoabdominal Aortic Aneurysms

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04009512
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 6, 2020
Completion date	August 26, 2026

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