B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEric Roselli, M. D.
About this trial
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 criteria
Qualifiers
At least 18 years of age
Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study.
Expected life expectancy of greater than two years after repair
Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair
Disqualifiers
Subject is unfit for open surgical repair involving circulatory arrest
Subject is comatose or suffering from irreversible severe brain malperfusion
Subject has known sensitivity to components of the devices
Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
Trial design
Treatments tested in this trial
- B-SAFER
Treatment groups
590 Participants
are divided into 1 treatment groupSponsors and collaborators
Eric Roselli, M. D.
Lead sponsor
The Cleveland Clinic
Sponsor institution
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov