B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER)

October 7, 2025 updated by: Eric Roselli, M. D.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
590

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eric Roselli, M. D.
  • Phone Number: 216-444-0995
  • Email: roselle@ccf.rg

Study Contact Backup

  • Name: Yuki Kuramochi, BSN, RN
  • Phone Number: 2164454063
  • Email: kuramoy@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
          • Yuki Kuramochi, BSN, RN
          • Phone Number: 216-445-4063
          • Email: kuramoy@ccf.org
        • Principal Investigator:
          • Eric Roselli, M. D.
        • Sub-Investigator:
          • Faisal Bakaeen, M. D.
        • Sub-Investigator:
          • Patrick Vargo, M. D.
        • Sub-Investigator:
          • Edward Soltez, M. D.
        • Sub-Investigator:
          • Michael Tong, M. D.
        • Sub-Investigator:
          • Shinya Unai, M. D.
        • Sub-Investigator:
          • Haytham Elgharably, M. D.
        • Sub-Investigator:
          • Francis Caputo, M. D.
        • Sub-Investigator:
          • Lee Kirksey, M. D.
        • Sub-Investigator:
          • John Quatromoni, M. D.
        • Sub-Investigator:
          • Marc Gillinov, M. D.
        • Sub-Investigator:
          • Marijan Koprivanac, M. D.
        • Sub-Investigator:
          • Sean Steenberge, M. D.
        • Sub-Investigator:
          • Ali Khalifeh, M. D.
        • Sub-Investigator:
          • Ravi Ambani, M. D.
        • Sub-Investigator:
          • Anthony Zaki, M. D.
        • Sub-Investigator:
          • Tarek Malas, M. D.
        • Sub-Investigator:
          • Xiaoying Lou, M. D.
        • Sub-Investigator:
          • Donna Kilmmaliardjuk, M. D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Up to 30 days
Individual rate of occurrence of the death from all-cause
Up to 30 days
Stroke, excluding TIA
Time Frame: Up to 30 days
Individual rate of occurrence of stroke
Up to 30 days
Paralysis, excluding paraparesis
Time Frame: Up to 30 days
Individual rate of occurrence of paralysis
Up to 30 days
Technical success
Time Frame: 24 hours
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
Time Frame: At hospital discharge or at 1 month
Patent graft/endografts confirmed by CT imaging assessment
At hospital discharge or at 1 month
Complete sealing of the aortic pathology
Time Frame: At hospital discharge or 1 month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aortic related death
Time Frame: Up to 36 months after the index procedure
Individual rate of the aortic related death
Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Time Frame: Up to 36 months after the index procedure
Individual rate of the pseudoaneurysm at the treatment sites
Up to 36 months after the index procedure
Unanticipated aortic or branch-related re-operation
Time Frame: Up to 36 months after the index procedure
Individual rate of the unanticipated aortic or branch-related re-operation
Up to 36 months after the index procedure
Late Type I endoleak
Time Frame: Up to 36 months after the index procedure
Individual rate of the Type I endoleak confirmed by CT imaging assessment
Up to 36 months after the index procedure
Late Type III endoleak
Time Frame: Up to 36 months after the index procedure
Individual rate of the Type III endoleak confirmed by CT imaging assessment
Up to 36 months after the index procedure
Non-cardiac/non-aortic re-operations
Time Frame: Up to 36 months after the index procedure
Individual rate of non-cardiac/non-aortic re-operations
Up to 36 months after the index procedure
Vocal Cord paralysis
Time Frame: Up to 36 months after the index procedure
Individual rate of vocal cord paralysis
Up to 36 months after the index procedure
Myocardial infarction
Time Frame: Up to 36 months after the index procedure
Individual rate of myocardial infarction
Up to 36 months after the index procedure
Respiratory failure
Time Frame: Up to 36 months after the index procedure
Individual rate of respiratory failure
Up to 36 months after the index procedure
Renal failure requiring dialysis
Time Frame: Up to 36 months after the index procedure
Individual rate of renal failure requiring dialysis
Up to 36 months after the index procedure
Thromboembolic events
Time Frame: Up to 36 months after the index procedure
Individual rate of thromboembolic events
Up to 36 months after the index procedure
Failed patencies in graft, or endovascular stent-graft including the branch(es)
Time Frame: Up to 36 months after the index procedure
Individual rate of failed patencies in gaft or endovascular stent-graft including branch(es)
Up to 36 months after the index procedure
Secondary unplanned interventions in the treated vascular segment or related to the original pathology
Time Frame: Up to 36 months after the index procedure
Individual rate of secondary unplanned interventions in the treated vascular segment or related to the original pathology
Up to 36 months after the index procedure
Aortic rupture
Time Frame: Up to 36 months after the index procedure
Individual rate of aortic rupture
Up to 36 months after the index procedure
Device integrity failures
Time Frame: Up to 36 months after the index procedure
Individual rate of device integrity failures confirmed by CT imaging assessment
Up to 36 months after the index procedure
Device crimping/kinking
Time Frame: Up to 36 months after the index procedure
Individual rate of device crimping/kinking confirmed by CT imaging assessment
Up to 36 months after the index procedure
Device migration
Time Frame: Up to 36 months after the index procedure
Individual rate of device migration (>10 mm based on the position of the device implantation) compared to baseline confirmed by CT imaging assessment
Up to 36 months after the index procedure
Thrombosis of the device lumen
Time Frame: Up to 36 months after the index procedure
Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment
Up to 36 months after the index procedure
Surgical graft/stentgraft infection
Time Frame: Up to 36 months after the index procedure
Individual rate of surgical graft/stentgraft infection
Up to 36 months after the index procedure
Incidence of all endoleak types
Time Frame: Up to 36 months after the index procedure
Individual rate of all endoleak types confirmed by CT imaging assessment
Up to 36 months after the index procedure
Migration of the distal extension
Time Frame: Up to 36 months after the index procedure
Individual rate of distal extension migration (>10 mm based on the position of the device implantation) confirmed by CT imaging assessment
Up to 36 months after the index procedure
Non-serious and serious adverse events
Time Frame: Up to 36 months after the index procedure
Individual rate of non-serious adverse events
Up to 36 months after the index procedure
Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device
Time Frame: Up to 36 months after the index procedure
Individual rate of the extension device integrity issues confirmed by CT imaging assessment
Up to 36 months after the index procedure
Incidence of Type III endoleak related to the extension device
Time Frame: Up to 36 months after the index procedure
Individual rate of the Type III endoleak related to the extension device confirmed by CT imaging assessment
Up to 36 months after the index procedure
Incidence of failed patency of the device-extension overlap
Time Frame: Up to 36 months after the index procedure
Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment
Up to 36 months after the index procedure
Incidence of MAE at 30 days post-extension
Time Frame: Up to 36 months after the index procedure
Individual rate and type of MAE at 30 days post-extension
Up to 36 months after the index procedure
Incidence of secondary procedures related to the extension
Time Frame: Up to 36 months after the index procedure
Individual rate secondary procedures related to the extension
Up to 36 months after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eric Roselli, M. D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Roselli, M. D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G200342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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