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NCT04747626: B-SAFER

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Recruiting now NA Last updated 9 October 2025
What this trial tests

NA trial testing B-SAFER in Thoracic Aortic Aneurysm in 590 participants. Currently enrolling.

Timeline
25 March 2021
Primary endpoint
31 December 2030
31 December 2030

Quick facts

Lead sponsorEric Roselli, M. D.
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment590
Start date25 March 2021
Primary completion31 December 2030
Estimated completion31 December 2030
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eric Roselli, M. D.

Who can join

18 and older, any sex, with Thoracic Aortic Aneurysm or Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hybrid repair versus conventional open repair for thoracic aortic arch aneurysms.
    Elhelali A, Hynes N, Devane D, Sultan S, et al · · 2021 · cited 13× · PMID 34085713 · DOI 10.1002/14651858.cd012923.pub2
  2. Anomalous left vertebral artery in patients undergoing total arch replacement: Results from a prospective trial.
    Bhagat R, Snyder A, Vargo P, Hussain MS, et al · · 2026 · PMID 41971881 · DOI 10.1016/j.xjtc.2026.102270
  3. Aortic Dissection Registries: The Tools to Keep Us in Check.
    Koprivanac M, Roselli EE, Bakaeen FG. · · 2022 · PMID 36713765 · DOI 10.1016/j.jacasi.2022.09.009

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Other recruiting trials for Thoracic Aortic Aneurysm

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04747626.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing