B-SAFER for Thoracic Aortic Aneurysm and Aortic Dissection
This study is testing a new surgical technique called B-SAFER (Branched Stented Anastomosis Frozen Elephant Trunk Repair) for people with serious aortic conditions like thoracic aortic aneurysm (a bulge in the main artery from your heart) or aortic dissection (a tear in the aorta). The B-SAFER technique uses a modified stentgraft (a tube-like device) to treat multiple sections of the aorta. The study aims to see how safe and effective this new approach is. Researchers will be looking at important outcomes like death, stroke, and paralysis within 30 days of the procedure. You might be able to join if you are at least 18 years old and are expected to live more than two years after the repair. The study is currently unclear on its recruitment status.
- Study design
- This is a single-center study that is not blinded or randomized, meaning participants are not assigned to different groups by chance. It plans to enroll up to 590 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for outcomes like death, stroke, and paralysis for up to 30 days after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Eric Roselli, M. D. · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
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What this trial measures
- All-cause mortalityUp to 30 days
Individual rate of occurrence of the death from all-cause
- Stroke, excluding TIAUp to 30 days
Individual rate of occurrence of stroke
- Paralysis, excluding paraparesisUp to 30 days
Individual rate of occurrence of paralysis
- Technical success24 hours
Composite of the following criteria: successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival
- Patency of all graft/endograft componentsAt hospital discharge or at 1 month
Patent graft/endografts confirmed by CT imaging assessment
- Complete sealing of the aortic pathologyAt hospital discharge or 1 month
Absence of Type Ia and IIIa/b endoleak, complete coverage of PAU cases, and isolation of the primary entry tear in dissection cases confirmed by CT imaging assessment