B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Launched by ERIC ROSELLI, M. D. · Feb 5, 2021

Keywords

ClinConnect Summary

The B-SAFER trial is studying a new way to repair serious problems with the thoracic aorta, which is the large blood vessel that carries blood from the heart to the rest of the body. This trial focuses on patients with conditions like thoracic aortic aneurysms, aortic dissections (tears in the aorta), or congenital aortic anomalies (problems present at birth). The goal is to see if a special hybrid repair technique is safe and effective for patients who need surgery to fix multiple damaged areas of their aorta.

To be eligible for this trial, participants must be at least 18 years old and able to give consent or have a representative who can. They should also expect to live for more than two years after the surgery and need repair for their aortic condition. During the study, participants will undergo a procedure to repair their aorta, and their progress will be closely monitored. It's important to note that some individuals may not be eligible, such as those with certain health issues or infections that could complicate the surgery. Overall, this trial aims to improve treatment options for patients with these serious aortic conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age
• • 2. 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.
• • 3. Expected life expectancy of greater than two years after repair
• • 4. 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
• Exclusion Criteria:
• • 1. Subject is unfit for open surgical repair involving circulatory arrest
• • 2. Subject is comatose or suffering from irreversible severe brain malperfusion
• • 3. Subject has known sensitivity to components of the devices
• • 4. Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• • 5. 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
• • 6. Subject has an uncorrectable bleeding anomaly
• • 7. 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
• • 8. Subject is pregnant