Thoracic Stent-Graft for Thoracic Aortic Injury

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen byBen Starnes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bolton Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

This trial is for adults over 18 with a recent traumatic injury to the descending thoracic aorta. Candidates must have specific aortic dimensions, be willing to follow up, and consent to treatment. Exclusions include severe artery issues, other major heart or lung conditions, allergies to device materials, recent stroke or heart attack, chronic kidney failure not on dialysis, life expectancy under two years, certain anatomical variants affecting blood flow after device placement.

Inclusion Criteria

Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment

My aorta's affected area is between my neck artery and the artery to my stomach.

I am older than 18 years.

+4 more

Exclusion Criteria

You have a very serious injury.

Currently pregnant or planning to become pregnant during the course of the study

I need surgery for an aneurysm in my chest or abdomen.

+17 more

Participant Groups

The study tests the Relay Pro Thoracic Stent-Graft System's safety and effectiveness in repairing traumatic injuries of the descending thoracic aorta. Participants will receive this stent-graft system and their recovery and outcomes will be monitored.

1Treatment groups

Experimental Treatment

Group I: Relay Pro Thoracic Stent-Graft SystemExperimental Treatment1 Intervention

The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System