Thoracic Stent-Graft for Thoracic Aortic Injury

Not currently recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Disqualifiers: Coronary artery disease, Severe heart failure, Stroke, others

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

Compensation: Varies

Number of Visits: 2

Duration: During Implantation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new device called the RelayPro Thoracic Stent-Graft System. The device is designed to assist individuals who have recently experienced a traumatic injury to the descending thoracic aorta, a major blood vessel in the chest. This trial may suit someone who sustained such an injury within the past 30 days and is willing to participate in follow-up appointments with doctors. As an unphased study, this trial offers a unique opportunity to contribute to medical advancements and potentially benefit from cutting-edge treatment.

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 prior data suggests that the RelayPro Thoracic Stent-Graft System is safe for treating thoracic aortic injury?

Research has shown that the RelayPro Thoracic Stent-Graft System is generally well-tolerated by adults with conditions affecting the thoracic aorta. Safety data from earlier studies indicate that patients using the RelayPro experienced few side effects. The stent-graft fits securely in the aorta, reducing complications during and after the procedure. Additionally, the FDA has approved the system for treating other aortic conditions, suggesting its safety. While no treatment is without risk, evidence suggests that the RelayPro is a safe option for treating injuries in the thoracic aorta. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Relay Pro Thoracic Stent-Graft System is unique because it offers a minimally invasive approach to treating traumatic injuries of the descending thoracic aorta. Unlike traditional open surgery, which requires large incisions and can be risky, this stent-graft system is delivered endovascularly, meaning it is inserted through a small incision and guided to the injury site via blood vessels. Researchers are excited about this treatment because it has the potential to reduce recovery time and lower the risk of complications associated with open surgery. Additionally, it provides a targeted repair option that can adapt to the unique anatomy of each patient, offering more personalized care.

What evidence suggests that the RelayPro Thoracic Stent-Graft System is effective for thoracic aortic injury?

Research has shown that the RelayPro Thoracic Stent-Graft System effectively treats issues with the descending thoracic aorta (DTA), a major blood vessel in the chest. Studies have found it safe and effective within 30 days and one year for patients with aneurysms (bulges in blood vessels) and penetrating ulcers in the DTA. This stent-graft is also designed to treat specific types of aneurysms, such as fusiform and saccular aneurysms. In this trial, participants will receive the RelayPro system to support the damaged aorta and aid healing, which is crucial for injuries caused by trauma. Although primarily studied for aneurysms, the same principles suggest it could also be effective for traumatic aortic injuries. ^{2 3 5 6 7}

Who Is on the Research Team?

Ben Starnes, MD

Principal Investigator

University of Washington

Ravi Rajani, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03090230

Study of the Relay Pro® Thoracic Stent-Graft in Subjects ... RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045S002B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Relay®Pro Thoracic Stent-Graft System (referred to as RelayPro hereafter) is designed to treat fusiform aneurysms and saccular aneurysms/ ...

3. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/01/RelayPro-Key-Studies-Brochure-Letter-PM-08876-USA-CAN-1.pdf

Relay®Pro: Key Studies Relay®Pro demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the DTA and PAUs . Patient with a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0890509619300342

Prospective Multicenter Study of the Low-Profile Relay ... To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03033043

Study of the RelayPro Thoracic Stent-Graft in Subjects With ... This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The RelayPro consists of two types of implants, namely the proximal bare stent configuration and the non-bare stent (NBS) configuration. The RelayPro is a next ...

7. terumoaortic.com terumoaortic.com/products/relaypro/

RelayPro | Uniquely Inspired for Ideal Placement The RelayPro Thoracic Stent-Graft System is intended to treat various thoracic aortic pathologies in adult patients.