NCT03090230

Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)

Detailed description

This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are candidates for endovascular repair.The primary objective of the study is all-cause mortality at 30 days post procedure. The secondary objectives of the trial will include descriptive analyses of procedural and post-procedural observations through 5 years of follow-up.

Conditions

• Other Specified Injury of Thoracic Aorta

Interventions

Type	Name	Description
DEVICE	Relay Pro Thoracic Stent-Graft System	RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The device is designed specifically for use in the thoracic aorta.

Timeline

• Start date: 2017-04-17
• Primary completion: 2020-12-22
• Completion: 2025-11-22
• First posted: 2017-03-24
• Last updated: 2025-05-31

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study