Thoracic Stent-Graft for Aortic Aneurysm (RelayBranch Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Luis A Sanchez, MD, FACS - Washington ...

Overseen ByLuis Sanchez, M.D

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bolton Medical

No Placebo Group

Trial Summary

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.

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.

My blood vessels in the neck meet the required size criteria.

I have a type B aortic dissection that is stable and not causing complications.

I have an abnormal bulge in the upper part of my aorta.

I have an aneurysm in the upper part of my aorta.

My aorta's upper and lower ends meet the specific size requirements.

I am at high risk for surgery due to my health condition.

My condition has not improved despite receiving the best available treatment.

I am 18 years old or older.

Exclusion Criteria

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

My blood pressure and heart rate are unstable.

I have a connective tissue disorder, mycotic aneurysm, or infected aorta.

My aorta's curve near the heart is less than 15mm.

Both of my subclavian arteries will be blocked or covered before a procedure.

My blood flow in both vertebral arteries might be affected by a stent placement.

I have had a procedure to repair my thoracic aorta.

I need surgery for an aneurysm or disease in my abdominal aorta.

I have severe heart failure (NYHA class IV).

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

I have a major blockage in my carotid artery.

I had surgery for an abdominal aortic aneurysm less than 6 months ago.

My blood vessels at certain sites are narrowed, hardened, or twisted.

I am currently experiencing sudden kidney failure.

I have severe lung disease.

I do not have an active infection.

I have been diagnosed with a type of heart condition known as Acute Coronary Syndrome.

I have not had a stroke in the last year.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Relay Branch SystemExperimental Treatment1 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.