Thoracic Aortic AneurysmB-SAFERNCT04747626
B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
A study testing B-SAFER in people with Thoracic Aortic Aneurysm and Aortic Dissection, run by Eric Roselli, M. D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly
- What is being tested?
- B-SAFER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Eric Roselli, M. D., 216-444-0995, roselle@ccf.org
Yuki Kuramochi, BSN, RN, 216-445-4063, kuramoy@ccf.org
About this study
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.
Read the 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.
- Being tested
- B-SAFER
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-SAFERDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments. Receives: Device: B-SAFER |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Individual rate of occurrence of the death from all-cause
Measured: Up to 30 days
Stroke, excluding TIA
Individual rate of occurrence of stroke
Measured: Up to 30 days
Paralysis, excluding paraparesis
Individual rate of occurrence of paralysis
Measured: 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
Measured: 24 hours
Patency of all graft/endograft components
Patent graft/endografts confirmed by CT imaging assessment
Measured: 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
Measured: At hospital discharge or 1 month
Secondary outcomes (27)
Aortic related death
Individual rate of the aortic related death
Measured: Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Individual rate of the pseudoaneurysm at the treatment sites
Measured: Up to 36 months after the index procedure
Unanticipated aortic or branch-related re-operation
Individual rate of the unanticipated aortic or branch-related re-operation
Measured: Up to 36 months after the index procedure
Late Type I endoleak
Individual rate of the Type I endoleak confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Late Type III endoleak
Individual rate of the Type III endoleak confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Non-cardiac/non-aortic re-operations
Individual rate of non-cardiac/non-aortic re-operations
Measured: Up to 36 months after the index procedure
Vocal Cord paralysis
Individual rate of vocal cord paralysis
Measured: Up to 36 months after the index procedure
Myocardial infarction
Individual rate of myocardial infarction
Measured: Up to 36 months after the index procedure
Respiratory failure
Individual rate of respiratory failure
Measured: Up to 36 months after the index procedure
Renal failure requiring dialysis
Individual rate of renal failure requiring dialysis
Measured: Up to 36 months after the index procedure
Thromboembolic events
Individual rate of thromboembolic events
Measured: Up to 36 months after the index procedure
Failed patencies in graft, or endovascular stent-graft including the branch(es)
Individual rate of failed patencies in gaft or endovascular stent-graft including branch(es)
Measured: Up to 36 months after the index procedure
Secondary unplanned interventions in the treated vascular segment or related to the original pathology
Individual rate of secondary unplanned interventions in the treated vascular segment or related to the original pathology
Measured: Up to 36 months after the index procedure
Aortic rupture
Individual rate of aortic rupture
Measured: Up to 36 months after the index procedure
Device integrity failures
Individual rate of device integrity failures confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Device crimping/kinking
Individual rate of device crimping/kinking confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Device migration
Individual rate of device migration (>10 mm based on the position of the device implantation) compared to baseline confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Thrombosis of the device lumen
Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Surgical graft/stentgraft infection
Individual rate of surgical graft/stentgraft infection
Measured: Up to 36 months after the index procedure
Incidence of all endoleak types
Individual rate of all endoleak types confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Migration of the distal extension
Individual rate of distal extension migration (>10 mm based on the position of the device implantation) confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Non-serious and serious adverse events
Individual rate of non-serious adverse events
Measured: 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
Individual rate of the extension device integrity issues confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Incidence of Type III endoleak related to the extension device
Individual rate of the Type III endoleak related to the extension device confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Incidence of failed patency of the device-extension overlap
Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment
Measured: Up to 36 months after the index procedure
Incidence of MAE at 30 days post-extension
Individual rate and type of MAE at 30 days post-extension
Measured: Up to 36 months after the index procedure
Incidence of secondary procedures related to the extension
Individual rate secondary procedures related to the extension
Measured: Up to 36 months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start25 Mar 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Roselli, M. D.
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Eric Roselli, M. D., The Cleveland Clinic
- Investigators
- Eric Roselli, M. D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747626
- Sponsor's protocol ID
- G200342
- Acronym
- B-SAFER
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2021
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5.
PubMed 37802330
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
- ClinicalTrials.gov ID
- NCT04747626
- Acronym / sponsor ID
- B-SAFER / G200342
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Eric Roselli, M. D.University, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: B-SAFERImplantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-SAFERSimplified 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. | Device | Treatment |
Primary outcome
All-cause mortality
Time frame: Up to 30 days
Individual rate of occurrence of the death from all-cause
Stroke, excluding TIA
Time frame: Up to 30 days
Individual rate of occurrence of stroke
Paralysis, excluding paraparesis
Time frame: Up to 30 days
Individual rate of occurrence of paralysis
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
Patency of all graft/endograft components
Time frame: At hospital discharge or at 1 month
Patent graft/endografts confirmed by CT imaging assessment
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
27 secondary outcomes
Aortic related death
Time frame: Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Time frame: 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
Late Type I endoleak
Time frame: Up to 36 months after the index procedure
Late Type III endoleak
Time frame: Up to 36 months after the index procedure
Non-cardiac/non-aortic re-operations
Time frame: Up to 36 months after the index procedure
Vocal Cord paralysis
Time frame: Up to 36 months after the index procedure
Myocardial infarction
Time frame: Up to 36 months after the index procedure
Respiratory failure
Time frame: Up to 36 months after the index procedure
Renal failure requiring dialysis
Time frame: Up to 36 months after the index procedure
Thromboembolic events
Time frame: 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
Secondary unplanned interventions in the treated vascular segment or related to the original pathology
Time frame: Up to 36 months after the index procedure
Aortic rupture
Time frame: Up to 36 months after the index procedure
Device integrity failures
Time frame: Up to 36 months after the index procedure
Device crimping/kinking
Time frame: Up to 36 months after the index procedure
Device migration
Time frame: Up to 36 months after the index procedure
Thrombosis of the device lumen
Time frame: Up to 36 months after the index procedure
Surgical graft/stentgraft infection
Time frame: Up to 36 months after the index procedure
Incidence of all endoleak types
Time frame: Up to 36 months after the index procedure
Migration of the distal extension
Time frame: Up to 36 months after the index procedure
Non-serious and serious adverse events
Time frame: 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
Incidence of Type III endoleak related to the extension device
Time frame: 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
Incidence of MAE at 30 days post-extension
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Derived from this study: PubMed 37802330Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Roselli, M. D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-SAFER in people with Thoracic Aortic Aneurysm and Aortic Dissection, run by Eric Roselli, M. D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Roselli, M. D. (216-444-0995, roselle@ccf.rg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Up to 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.