Thoracic Stent-Graft for Aortic Aneurysm

(RelayBranch Trial)

Recruiting at 12 trial locations

Overseen By Valerie DePetrillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Must not be taking: Anticoagulants

Disqualifiers: Stroke, Myocardial infarction, Severe CHF, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on blood thinners or have a bleeding disorder, you may need to stop them for a week before and after the procedure. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment RelayBranch Thoracic Stent-Graft System for aortic aneurysm?

Research shows that the Relay thoracic stent graft has been effective and safe for repairing the aorta in patients with thoracic aortic disease, including aneurysms and dissections, which suggests it may also be effective for aortic aneurysms. ^{1 2 3 4 5}

Is the Thoracic Stent-Graft for Aortic Aneurysm safe for humans?

Research shows that the Relay Thoracic Stent-Graft, including versions like RelayPlus and RelayPro, has been evaluated for safety in treating thoracic aortic conditions. Studies indicate it is generally safe, with the FDA approving the RelayPlus system in 2012 based on adequate safety data. ^{1 2 3 6 7}

How is the RelayBranch Thoracic Stent-Graft System treatment different from other treatments for aortic aneurysms?

The RelayBranch Thoracic Stent-Graft System is unique because it is specifically designed for endovascular repair (a minimally invasive procedure using a tube-like device) of thoracic aortic aneurysms, potentially reducing the risk of complications compared to traditional open surgery. This system may offer a less invasive option with a focus on treating complex aneurysms in the thoracic aorta. ^{4 8 9 10 11}

What is the purpose of this trial?

The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.

Research Team

Luis Sanchez, M.D

Principal Investigator

Barnes Jewish Hospital, Washington Univ

Wilson Szeto, MD

Principal Investigator

Penn Presbyterian Medical Center

Eligibility Criteria

This trial is for adults with specific types of aortic aneurysms or penetrating ulcers in the ascending aorta, arch, or proximal descending thoracic aorta. Candidates must have anatomy suitable for the stent-graft system and be willing to follow up after treatment. Exclusions include severe allergies to device materials, certain heart and lung conditions, recent major procedures, systemic infections, renal failure, and other investigational study involvement.

Inclusion Criteria

My treatment would involve covering key arteries near my heart with a graft.

There are specific rules for where the graft attaches to the arch of the blood vessel.

Your blood vessels need to be a certain size and length for the study.

Exclusion Criteria

The area where the graft needs to be placed is too close to important blood vessels.

I am on blood thinners for a heart rhythm problem or a clotting disorder.

My blood pressure and heart rate are unstable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Index Procedure

Assessment of the safety and effectiveness of the Relay Branch System during the initial procedure

1 day

1 visit (in-person)

30-day Follow-up

Evaluation of device patency and technical success 30 days post-operation

4 weeks

1 visit (in-person)

90-day Follow-up

Assessment of major adverse events including mortality, stroke, and other complications

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• RelayBranch Thoracic Stent-Graft System

Trial Overview The RelayBranch Thoracic Stent-Graft System is being tested for safety and effectiveness in treating thoracic aortic aneurysms. The trial involves implanting this device into patients' affected arteries and monitoring them closely at initial deployment and again after 30 days to assess how well it works.

Participant Groups

Group I: Relay Branch System Experimental Treatment 1 Intervention

Subjects who receive the Relay Branch System for repair which includes those with aneurysmal disease, penetrating atherosclerotic ulcer (PAU), and chronic uncomplicated Type B aortic dissection.

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

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

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

Complications after endovascular treatment of thoracic aortic aneurysms. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Improved outcomes with endovascular stent grafts for thoracic aorta transections. [2021]

6. 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]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database. [2022]

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

Type A dissection following endovascular thoracic aortic stent-graft repair. [2022]

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

Challenges of endovascular tube graft repair of thoracic aortic aneurysm: midterm follow-up and lessons learned. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Endovascular treatment of the descending thoracic aorta. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The use of stent grafts for the treatment of aneurysms and dissections of the thoracic aorta: a single centre experience. [2022]