B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

NCT04747626 | Recruiting DMC FDA Device

• 1 other identifier: G200342
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• All-cause mortality

  Individual rate of occurrence of the death from all-cause

  Up to 30 days

• Stroke, excluding TIA

  Individual rate of occurrence of stroke

  Up to 30 days

• Paralysis, excluding paraparesis

  Individual rate of occurrence of paralysis

  Up to 30 days

• Technical success

  Composite of the following criteria: successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival

  24 hours

• Patency of all graft/endograft components

  Patent graft/endografts confirmed by CT imaging assessment

  At hospital discharge or at 1 month

• Complete sealing of the aortic pathology

  Absence of Type Ia and IIIa/b endoleak, complete coverage of PAU cases, and isolation of the primary entry tear in dissection cases confirmed by CT imaging assessment

  At hospital discharge or 1 month

Secondary Outcomes (27)

• Aortic related death

  Up to 36 months after the index procedure

• Pseudoaneurysm at the treatment sites

  Up to 36 months after the index procedure

• Unanticipated aortic or branch-related re-operation

  Up to 36 months after the index procedure

• Late Type I endoleak

  Up to 36 months after the index procedure

• Late Type III endoleak

  Up to 36 months after the index procedure

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: B-SAFER

Interventions

B-SAFER DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• 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.
• Expected life expectancy of greater than two years after repair
• 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

You may not qualify if:

• Subject is unfit for open surgical repair involving circulatory arrest
• Subject is comatose or suffering from irreversible severe brain malperfusion
• Subject has known sensitivity to components of the devices
• Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• 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
• Subject has an uncorrectable bleeding anomaly
• 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
• Subject is pregnant

Sponsors & Collaborators

• Eric Roselli, M. D.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Dissection

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Eric Roselli, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Roselli, M. D.

CONTACT

216-444-0995; roselle@ccf.rg

Yuki Kuramochi, BSN, RN

CONTACT

2164454063; kuramoy@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Principal Investigator

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: March 25, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)