RecruitingNot ApplicableNCT04747626

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair


Sponsor

Eric Roselli, M. D.

Enrollment

590 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a surgical technique called the Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) for patients who need repair of multiple diseased sections of the thoracic aorta — the large artery that runs through the chest. This can include aneurysms (dangerous bulges), acute dissections (tears), or congenital aortic problems. The procedure involves open heart surgery with a period where the heart is temporarily stopped (circulatory arrest). It is designed for complex cases where several parts of the aorta need to be repaired at once. The study tracks safety and outcomes for patients who receive this combined repair. You may be eligible if... - You are 18 years or older - You need repair of multiple diseased or damaged sections of the thoracic aorta - Your condition includes aneurysm, acute dissection, or congenital aortic disease - You are expected to live more than 2 years after the procedure - You are able to give informed consent You may NOT be eligible if... - You are not able to undergo open surgery requiring circulatory arrest - You are comatose or have severe irreversible brain damage - You are pregnant - You have an active systemic infection that could compromise the surgery - You have a bleeding disorder that cannot be corrected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEB-SAFER

Simplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments.


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT04747626


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