RelayPro Stent-Graft for Thoracic Aortic Aneurysm

(RelayPro-A Trial)

Recruiting at 36 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)

110 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

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 data supports the effectiveness of the treatment RelayPro Stent-Graft for Thoracic Aortic Aneurysm?

Research shows that the RelayPro Stent-Graft is effective in treating thoracic aortic disease, with studies indicating its safety and good performance in patients with thoracic aortic aneurysms and other related conditions. ^{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 thoracic aortic diseases, including aneurysms and dissections. Research shows it has been evaluated for safety and clinical performance, with studies indicating adequate safety data. The device has been used in various conditions, and no significant safety concerns have been reported in these studies. ^{1 2 3 5 6}

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

The RelayPro Stent-Graft is unique because it is a low-profile system designed specifically for the curvature and complexity of the thoracic aorta, making it easier to use in endovascular procedures (minimally invasive surgeries inside blood vessels). This design helps improve safety and performance compared to other stent-grafts. ^{1 2 3 4 5}

Research Team

Wilson Szeto, MD

Principal Investigator

Penn Presbyterian

Venkatesh Ramaiah, MD

Principal Investigator

Arizona Heart Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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

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

4. 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]

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

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

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

One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies. [2022]