RelayPro Stent-Graft for Aortic Dissection

Recruiting at 32 trial locations

Overseen By Gretchen Wild

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: 1 day

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called RelayPro to help patients with severe tears in their main artery. The device supports the artery from the inside, helping it heal and preventing further damage. RelayPro is a second-generation, low-profile thoracic endograft developed by Terumo Aortic, designed for treating thoracic aortic aneurysm or penetrating atherosclerotic ulcer.

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 data supports the effectiveness of the RelayPro Thoracic Stent-Graft treatment for aortic dissection?

Research shows that the RelayPro Thoracic Stent-Graft has been evaluated for safety and performance in treating thoracic aortic diseases, including dissections. Studies like the RESTORE II and the Regeneration Study indicate that this treatment is effective and safe for managing conditions similar to aortic dissection. ^{1 2 3 4 5}

Is the RelayPro Stent-Graft safe for use in humans?

The RelayPro Stent-Graft has been studied for safety in treating various thoracic aortic conditions, including dissections and aneurysms. Research shows it is generally safe, with studies reporting positive safety outcomes in both early and midterm evaluations. ^{1 2 3 4 6}

What makes the RelayPro Stent-Graft treatment unique for aortic dissection?

The RelayPro Stent-Graft is unique because it is a low-profile device designed specifically for thoracic aortic disease, allowing it to navigate the complex curves of the aorta more easily than some other treatments. This design can improve the safety and effectiveness of the procedure for patients with aortic dissections. ^{1 2 3 4 5}

Research Team

Christian Shults, MD, FACS

Principal Investigator

Medstar Washington Hospital Center

Peter J. Rossi

Principal Investigator

Medical College of WI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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

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

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

Endovascular treatment of patients with types A and B thoracic aortic dissection using Relay thoracic stent-grafts: results from the RESTORE Patient Registry. [2022]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection. [2023]