Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study.
Eric E Roselli, Patrick R Vargo, Faisal Bakaeen...
https://pubmed.ncbi.nlm.nih.gov/37802330Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04747626
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair for Thoracic Aortic Disease
Led by Eric Roselli, M. D. · Updated on 2025-10-09
590
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and early effectiveness of a new surgical technique called Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) for treating complex thoracic aortic diseases. This technique uses a specially modified endovascular stentgraft to repair multiple damaged areas of the aorta, particularly where the aortic arch is involved. The study aims to assess how well this hybrid repair method works and how safe it is for patients with conditions like thoracic aortic aneurysm, aortic dissection, or congenital aortic anomalies. The treatment involves implanting a physician-modified endovascular stentgraft designed for the proximal aorta. This simplified hybrid frozen elephant trunk repair technique is performed as part of the surgical procedure. The study focuses on device performance, including the functionality of multiple components used during the operation. Participants will undergo this device implantation as the experimental intervention. During the study, participants will be closely monitored for outcomes such as survival, stroke, paralysis, and technical success shortly after treatment. Follow-up assessments will include checking the patency and sealing of the graft components at hospital discharge or one month. Longer-term monitoring up to three years will evaluate complications like device failures, re-operations, infections, and other adverse events. This comprehensive follow-up helps to understand both the safety and durability of the B-SAFER repair over time.
CONDITIONS
Brief Title
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Who Can Participate
Age: 18Years +
All Genders
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 of more than two years after repair
- Have aortic pathology requiring repair or replacement of multiple damaged or diseased thoracic aorta segments, including thoracic aortic aneurysm at increased risk, acute aortic dissection needing urgent repair, or congenital aortic disease requiring repair
You will not qualify if you...
- Unfit for open surgical repair involving circulatory arrest
- Comatose or with irreversible severe brain malperfusion
- Known sensitivity to device components
- Active systemic infection that may affect surgical outcome
- Enrolled in another active study with investigational product use within 6 months prior to implant or not reached primary endpoint
- Uncorrectable bleeding disorder
- Medical, social, or psychological issues precluding treatment or evaluations
- Pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 day
Participants undergo the B-SAFER surgical procedure, which involves implantation of a physician-modified endovascular stentgraft to repair multiple segments of the thoracic aorta.
1 surgical visit
Post-operative Follow-up
Duration - Up to 36 months
Participants are monitored for safety and effectiveness outcomes including device functionality and complications after surgery.
Approximately 6 to 12 follow-up visits over 36 months
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
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Research Team
E
Eric Roselli, M. D.
Y
Yuki Kuramochi, BSN, RN
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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