B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Recruiting now · Not applicable
Conditions studied: Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly
In brief
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.
Key facts
- Study ID
- NCT04747626
- Run by
- Eric Roselli, M. D.
- People needed
- 590
- Starts
- 2021-03-25
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study
- Subject has an uncorrectable bleeding anomaly
- Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure
- Subject is pregnant
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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