Actively Recruiting
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Led by Eric Roselli, M. D. · Updated on 2025-10-09
590
Participants Needed
1
Research Sites
509 weeks
Total Duration
On this page
Sponsors
E
Eric Roselli, M. D.
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Willing and able to give written informed consent or have a legally authorized representative provide consent
- Expected life expectancy greater than two years after repair
- Aortic pathology requiring repair or replacement of multiple damaged or diseased segments of the thoracic aorta, including at least one of the following: thoracic aortic aneurysm at increased risk for rupture or complications, acute aortic dissection requiring urgent repair, or congenital aortic disease requiring repair
You will not qualify if you...
- Unfit for open surgical repair involving circulatory arrest
- Comatose or suffering from irreversible severe brain malperfusion
- Known sensitivity to components of the devices
- Active systemic infection that could compromise the surgical outcome
- Enrolled in another active study and received an investigational product within 6 months prior to implant or not reached primary endpoint of that study
- Uncorrectable bleeding anomaly
- Any other medical, social, or psychological problems that preclude receiving treatment and evaluations
- Pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
E
Eric Roselli, M. D.
CONTACT
Y
Yuki Kuramochi, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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