Recruiting

Branched Stented Anastomosis

Sponsor:

Eric Roselli, M. D.

Code:

NCT04747626

Conditions

Thoracic Aortic Aneurysm

Aortic Dissection

Congenital Aortic Anomaly

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

B-SAFER

Study Details

Brief summary:

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

Thoracic Aortic Aneurysm

Aortic Dissection

Congenital Aortic Anomaly

Study ID

NCT04747626

Start date

Mar 25, 2021

Status verified date

Oct, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

590 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Interventions

B-SAFER

Simplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Primary outcome measure

  • All-cause mortality [ Time Frame: Up to 30 days ]
  • Stroke, excluding TIA [ Time Frame: Up to 30 days ]
  • Paralysis, excluding paraparesis [ Time Frame: Up to 30 days ]
  • Technical success [ Time Frame: 24 hours ]
  • Patency of all graft/endograft components [ Time Frame: At hospital discharge or at 1 month ]
  • Complete sealing of the aortic pathology [ Time Frame: At hospital discharge or 1 month ]

Central Contacts and Locations

Central contacts

Eric Roselli, M. D.

216-444-0995roselle@ccf.rg

Yuki Kuramochi, BSN, RN

2164454063kuramoy@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Eric Roselli, M. D.

216-444-0995roselle@ccf.org

Yuki Kuramochi, BSN, RN

216-445-4063kuramoy@ccf.org

Principal Investigator:

Eric Roselli, M. D.

More Information

Sponsor

Eric Roselli, M. D.

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eric Roselli, M. D. on 2025-10-09.