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B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

NCT04747626 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2025-10-09

No results posted yet for this study

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.

Conditions

  • Thoracic Aortic Aneurysm
  • Aortic Dissection
  • Congenital Aortic Anomaly

Interventions

DEVICE

B-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.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Eric Roselli, M. D.

    lead OTHER

Principal Investigators

  • Eric Roselli, M. D. · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747626 on ClinicalTrials.gov