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Stent-Graft System

Thoracic Stent-Graft for Aortic Aneurysm (RelayBranch Trial)

N/A

Waitlist Available

Led By Luis Sanchez, MD

Research Sponsored by Bolton Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Anatomy that would require coverage of the brachiocephalic trunk (BCT) and/or left carotid arteries if a non-branch endograft were implanted

Non-aneurysmal BCT and left common carotid arteries with specific diameter requirements

Must not have

Chronic atrial fibrillation or other hypercoagulable condition requiring treatment with anticoagulants or presence of left atrial appendage thrombus

Hemodynamic instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the safety and effectiveness of a new device that will be used to treat aortic pathologies. The device will be delivered and deployed during the index procedure, and patency of branches and branch vessels will be assessed at 30-day follow-up.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include complications related to the stent-graft such as blood vessel damage during insertion, movement of the graft post-surgery (migration), blockage (occlusion), infection risk from surgery or device-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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

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

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

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My blood pressure and heart rate are unstable.

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

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

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

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

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I have had a procedure to repair my thoracic aorta.

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

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I have severe heart failure (NYHA class IV).

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

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I have a major blockage in my carotid artery.

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

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

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I am currently experiencing sudden kidney failure.

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I have severe lung disease.

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I do not have an active infection.

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

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I have not had a stroke in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above

This trial's timeline: 3 weeks for screening, Varies for treatment, and technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of Major Adverse Events (MAEs)

Secondary study objectives

Composite of the following Criteria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 27Eligibility criteria met