Thoracic Stent-Graft for Thoracic Aortic Injury

Recruiting at 15 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: During Implantation

50 Participants Needed

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)

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a blood coagulation disorder, treatment may need to be suspended for one week before and after the procedure.

What data supports the effectiveness of the treatment Relay Pro Thoracic Stent-Graft System for thoracic aortic injury?

Research shows that the Relay Pro Thoracic Stent-Graft System is effective in treating thoracic aortic injuries, as it offers a less invasive alternative to open chest surgery and has been successfully used in various thoracic aortic conditions, including aneurysms and dissections. ^{1 2 3 4 5}

Is the Thoracic Stent-Graft System safe for humans?

The Relay Thoracic Stent-Graft System has been studied for safety in various conditions, including thoracic aortic disease and aneurysms. Studies have shown it to be generally safe, with the FDA approving it in 2012 based on adequate safety data. ^{1 3 4 6 7}

How is the Relay Pro Thoracic Stent-Graft System treatment different from other treatments for thoracic aortic injury?

The Relay Pro Thoracic Stent-Graft System is unique because it offers a minimally invasive approach to treating thoracic aortic injuries, avoiding the need for open surgery, which typically involves a large chest incision and the use of a heart-lung machine. This system is designed to be low-profile, meaning it is smaller and potentially easier to insert, which can lead to quicker recovery times and less risk of complications compared to traditional surgical methods. ^{1 3 8 9 10}

Research Team

Ben Starnes, MD

Principal Investigator

University of Washington

Ravi Rajani, MD

Principal Investigator

Emory University

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RelayPro Thoracic Stent-Graft to treat traumatic injury of the descending thoracic aorta

During Implantation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for stent-graft patency, aortic rupture, and other complications

5 years

1 month, 6 months, 12 months, and annually through 5 years

Treatment Details

Interventions

• Relay Pro Thoracic Stent-Graft System

Trial Overview 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.

Participant Groups

Group I: Relay Pro Thoracic Stent-Graft System Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Findings from Research

In a study involving 40 adult trauma patients treated with the Relay stent graft for blunt thoracic aortic injury, technical success was achieved in all cases, demonstrating the safety and efficacy of this less invasive TEVAR approach.

Follow-up imaging showed complete exclusion of the traumatic tear and no significant complications, with a 2-year survival rate of 93.7%, indicating that the Relay stent graft effectively manages traumatic aortic injuries without major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular repair of traumatic thoracic aortic injury: final results from the relay endovascular registry for thoracic disease. Zipfel, B., Chiesa, R., Kahlberg, A., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease: The Regeneration Study. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Endovascular repair of traumatic thoracic aortic injury: final results from the relay endovascular registry for thoracic disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Worldwide results from the RESTORE II on elective endografting of thoracic aneurysms and dissections. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Endovascular repair of the descending aorta and the aortic arch with the Relay stent graft. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Endovascular management of a thoracic aortic disruption following failure of deployment of a parachute. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Single center experience with a new commercially available thoracic endovascular graft. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Endovascular stent-graft or open surgical repair for blunt thoracic aortic trauma: systematic review. [2018]