RelayPro Stent-Graft for Aortic Dissection

Recruiting at 33 trial locations

Overseen By Gretchen Wild

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: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests a new device called the RelayPro Thoracic Stent-Graft to treat acute, complicated type B aortic dissection. This condition occurs when a tear in the inner layer of the aorta, the large blood vessel branching off the heart, can lead to life-threatening problems. The trial aims to evaluate the device's performance by checking survival rates 30 days after the procedure. Suitable candidates have experienced symptoms of this condition for less than six weeks and have severe issues like organ malperfusion (poor blood flow to organs) or intractable pain. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could improve future treatments.

Will I have to stop taking my current medications?

The trial information 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 paused for one week before and after the procedure.

What prior data suggests that the RelayPro Thoracic Stent-Graft is safe for treating aortic dissection?

Research has shown that the RelayPro Thoracic Stent-Graft is generally well-tolerated for treating complex type B aortic dissection. This device, designed to help repair the aorta, the main artery in the heart, has been safely used in patients with this condition.

In previous studies, researchers measured safety by the rate of deaths from any cause within 30 days after the procedure. The results indicated that the device met safety expectations, with death rates considered acceptable for this type of treatment.

Overall, medical settings have used the RelayPro Stent-Graft with results suggesting it is safe for patients. No major unexpected safety issues have been reported, making it a promising option for those needing treatment for aortic dissection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RelayPro Thoracic Stent-Graft is unique because it offers a minimally invasive solution for complicated Type B aortic dissections. Unlike traditional surgical approaches, which can be highly invasive and require extended recovery times, the RelayPro system is designed to be deployed endovascularly, meaning it's inserted via a small incision and guided through the blood vessels to the site of the dissection. Researchers are excited about this treatment because its precision and less invasive nature may reduce recovery time and complications, potentially providing a safer and more efficient option for patients compared to conventional open surgery.

What evidence suggests that the RelayPro Thoracic Stent-Graft is effective for treating type B aortic dissection?

Studies have shown that the RelayPro Thoracic Stent-Graft effectively treats type B aortic dissections. Research indicates that this device is designed to repair the aorta, the large artery that carries blood from the heart to the rest of the body. Its smaller size suits patients with narrower blood vessels. Early findings suggest that the device is safe and can reduce the risk of serious complications after surgery. Importantly, the RelayPro has demonstrated promising results in lowering death rates within 30 days after the procedure. Participants in this trial will receive the RelayPro Stent-Graft to further evaluate its effectiveness and safety. ^{1 4 5 6 7}

Who Is on the Research Team?

Christian Shults, MD, FACS

Principal Investigator

Medstar Health Research Institute

Peter J. Rossi

Principal Investigator

Medical College of WI

Are You a Good Fit for This Trial?

This trial is for individuals with a recent (within 6 weeks) and severe type B aortic dissection, confirmed by imaging tests. Participants must have specific complications like organ malperfusion or rupture, suitable vascular access for the device, and an anatomy that fits the stent-graft requirements. Exclusions include prior major surgeries in affected areas, unstable heart conditions, severe lung disease requiring oxygen therapy, acute kidney failure not on dialysis, extreme obesity affecting imaging quality, among others.

Inclusion Criteria

My aortic dissection was diagnosed within 6 weeks of symptom onset and is causing severe complications.

The diameter of my aortic neck is between 19 mm and 42 mm.

My arteries are suitable for a specific medical device insertion.

Exclusion Criteria

I have not had a stroke or heart attack in the last 3 months.

I have had a traumatic injury to the main artery in my chest.

My blood vessels are not suitable for certain medical device placements.

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 for the treatment of acute, complicated type B aortic dissection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

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

What Are the Treatments Tested in This Trial?

Interventions

• RelayPro Thoracic Stent-Graft

Trial Overview The RelayPro Thoracic Stent-Graft system is being tested in patients with acute complicated type B aortic dissection. The study is prospective and non-randomized to evaluate if this stent can effectively treat the condition while monitoring all-cause mortality within 30 days after the procedure.

How Is the Trial Designed?

Group I: Experimental: Relay Pro Experimental Treatment 1 Intervention

The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03033043

Study of the RelayPro Thoracic Stent-Graft in Subjects With ... The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The above events support the safety of the RelayPro Thoracic Stent-Graft in patients with. Type B aortic dissections. Pro-T. For the RelayPro ...

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

Prospective Multicenter Study of the Low-Profile Relay ... The RelayPro has a 3–4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies.

4. veithsymposium.org veithsymposium.org/2024/abstracts/vei/729.pdf

Disclosures RelayPro Thoracic Stent-Graft System ... The primary endpoint is all-cause mortality at 30-days post-procedure. • The primary endpoint was compared to a Performance Goal (PG) of 25%.

5. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/01/Annual-Clinical-Update-for-RelayPlus-2023.pdf

Bolton Medical (dba Terumo Aortic) Relay Thoracic Stent- ... This annual clinical update provides a review of the ongoing experience with the Relay Thoracic. Stent-Graft System with Plus Delivery System (P110038), ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03033043

Study of the RelayPro Thoracic Stent-Graft in Subjects With ... The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.