New technique for repairing thoracic aortic conditions

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

This study is testing a new method to repair certain serious aortic conditions in patients by using a special type of stent to see if it is safe and effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 590 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT04747626 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and preliminary effectiveness of a novel hybrid repair technique called Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER) for patients with thoracic aortic pathologies. It focuses on individuals requiring repair of the aortic arch proximal to the innominate artery, utilizing a physician-modified endovascular stentgraft. The study is a prospective, single-center, non-blind, non-randomized investigation that will assess the functionality of the device and its components during the implantation process.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with thoracic aortic aneurysms, acute aortic dissections, or congenital aortic anomalies requiring repair of multiple segments.

Not a fit: Patients who are unfit for open surgical repair or have severe brain malperfusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this technique could provide a safer and more effective option for patients with complex thoracic aortic conditions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in hybrid repair techniques for thoracic aortic conditions.

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Eric Roselli, M. D. — The Cleveland Clinic
• Study coordinator: Eric Roselli, M. D.

Conditions Thoracic Aortic Aneurysm; Aortic Dissection; Congenital Aortic Anomaly