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.

NCT04747626

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Recruiting
NAAges 18+InterventionalTreatment
Eric Roselli, M. D.
~590 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:B-SAFER

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-cause mortality
Measured over Up to 30 days
+5 more outcomes measured
Thoracic Aortic Aneurysm
Aortic Dissection
Congenital Aortic Anomaly
1 sites across 1 states
Ohio1
  • Eric Roselli, M. D. · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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  • 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