NCT03637374

Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Detailed description

The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

Conditions

• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Visceral Manifold and Thoracic Bifurcation	Endovascular stent graft system
DEVICE	Unitary Manifold	Endovascular stent graft system
DEVICE	TAAA Debranching Stent Graft System	Endovascular stent graft system

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-03-21
• Completion: 2022-06-06
• First posted: 2018-08-20
• Last updated: 2022-08-19
• Results posted: 2022-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study