NCT00435942

Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.

Conditions

• Thoracic Aortic Aneurysms
• and Penetrating Atherosclerotic Ulcers

Interventions

Type	Name	Description
DEVICE	Relay Thoracic Stent-Graft	implant
PROCEDURE	Open Repair	Open surgery

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-04-01
• Completion: 2017-05-15
• First posted: 2007-02-16
• Last updated: 2018-01-16
• Results posted: 2017-09-05

Locations

27 sites across 1 country: United States