RelayPro Stent-Graft for Thoracic Aortic Aneurysm

(RelayPro-A Trial)

Not currently recruiting at 38 trial locations

Overseen By Valerie DePetrillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Disqualifiers: Aortic dissection, Connective tissue disorder, Coronary artery disease, Severe congestive heart failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: Hospitalization period (up to several days)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the RelayPro Thoracic Stent-Graft, a medical device used to support the aorta. It targets individuals with a thoracic aortic aneurysm (a bulge in the wall of the aorta in the chest) or penetrating atherosclerotic ulcers (a type of sore or breakdown in the artery wall) in the descending thoracic aorta. Participants must have the specific condition in their chest aorta and be anatomically suitable for the device. Those with these conditions who can attend follow-up appointments might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to important 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. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the RelayPro Thoracic Stent-Graft received positive feedback in earlier studies. In one study involving 31 patients, researchers evaluated the stent-graft's effectiveness and its impact on survival. None of the patients died from aneurysms or dissections, suggesting the treatment's safety.

Another report states that the RelayPro is approved for patients with traumatic aortic injuries, indicating it meets specific safety standards for these conditions.

Although all medical devices carry risks, evidence so far suggests that RelayPro is generally well-tolerated for its intended uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

RelayPro is unique because it offers an endovascular approach to treating thoracic aortic aneurysms, which means it can be placed inside the blood vessel without open surgery. This method is less invasive compared to traditional open surgical repair, potentially leading to quicker recovery times and fewer complications. Researchers are excited about RelayPro because it could provide a safer and more efficient option for patients who are at high risk for surgical intervention. Additionally, its design aims to improve the precision of aneurysm repair, which might enhance long-term outcomes for patients.

What evidence suggests that the RelayPro Stent-Graft is effective for thoracic aortic aneurysms?

Research has shown that the RelayPro stent-graft, which participants in this trial will receive, effectively treats serious artery problems such as thoracic aortic aneurysms (TAAs) and penetrating atherosclerotic ulcers (PAUs). Studies have found it to be safe and effective, with positive outcomes at both 30 days and one year post-treatment. Notably, key studies reported no aneurysm-related deaths. Overall, the RelayPro has a strong record of safety and effectiveness for these conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Wilson Szeto, MD

Principal Investigator

Penn Presbyterian

Venkatesh Ramaiah, MD

Principal Investigator

Arizona Heart Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thoracic aortic aneurysms or penetrating atherosclerotic ulcers, who can consent to treatment and follow the study plan. They must have suitable anatomy for the device. Excluded are those with other types of thoracic aorta diseases, significant vessel issues, compromised circulation, certain past procedures, allergies to contrast media/device materials, pregnant women or those planning pregnancy during the study, and various specified diseases.

Inclusion Criteria

I have a disease in the lower part of the artery in my chest.

Subject must be willing to comply with the follow-up evaluation schedule

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

Exclusion Criteria

Subjects that are pregnant or planning to become pregnant during the course of the study

I do not have conditions like aortic dissection or ruptured aneurysm.

I have poor blood flow in certain areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular treatment with the RelayPro Thoracic Stent-Graft

Hospitalization period (up to several days)

Treatment Visit through Discharge Visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging assessments at 1 month, 6 months, and 12 months

12 months

Multiple follow-up visits at 1 month, 6 months, and 12 months

Long-term follow-up

Continued monitoring for stent-graft patency and absence of complications

Beyond 12 months

What Are the Treatments Tested in This Trial?

Interventions

• RelayPro

Trial Overview The RelayPro Thoracic Stent-Graft's safety and effectiveness are being tested in patients with descending thoracic aorta conditions like aneurysms and ulcers. The stent-graft is designed as a minimally invasive option to repair these issues within the body's main artery.

How Is the Trial Designed?

Group I: RelayPro Experimental Treatment 1 Intervention

Endovascular treatment with the investigational device.

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1. jtcvs.org jtcvs.org/article/S0022-5223(22)00101-5/fulltext

One-year results with a low-profile endograft in subjects ... The RelayPro device (Terumo Aortic) demonstrated 1-year safety and effectiveness for the treatment of descending thoracic aneurysms and PAUs: ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35241276/

One-year results with a low-profile endograft in subjects ... Conclusions: The low-profile RelayPro thoracic endograft met the study primary end points and demonstrated satisfactory 30-day safety and 1-year effectiveness ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The RelayPro also has a reduced delivery profile compared to the RelayPlus. In the RelayPro Pivotal Study, there was 2 aneurysm-related deaths and no aneurysm.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02818972

NCT02818972 | RelayPro Thoracic Stent-Graft in Subjects ... The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022522322001015

One-year results with a low-profile endograft in subjects ... The low-profile RelayPro thoracic endograft met the study primary end points and demonstrated satisfactory 30-day safety and 1-year effectiveness.

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

Prospective Multicenter Study of the Low-Profile Relay ... The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. Results. A total of 31 patients were treated with ...

7. 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 traumatic aortic injuries. Conclusion. The risks of ...

8. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/01/RelayPro-Annual-Clinical-Update.docx

RelayPro – Annual Clinical Update 2022 The study was designed to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with fusiform aneurysms and saccular ...