An interventional study of B-SAFER in Thoracic Aortic Aneurysm, Aortic Dissection and Congenital Aortic Anomaly, sponsored by Eric Roselli, M. D.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Eric Roselli, M. D. · Not applicable, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's planned enrollment of 590 is above the median of 50 across 62 interventional studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →This is the only study on the registry with Eric Roselli, M. D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
All-cause mortality
Individual rate of occurrence of the death from all-cause
Time frame: Up to 30 days
Stroke, excluding TIA
Individual rate of occurrence of stroke
Time frame: Up to 30 days
Paralysis, excluding paraparesis
Individual rate of occurrence of paralysis
Time frame: 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
Time frame: 24 hours
Patency of all graft/endograft components
Patent graft/endografts confirmed by CT imaging assessment
Time frame: 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
Time frame: At hospital discharge or 1 month
Aortic related death
Individual rate of the aortic related death
Time frame: Up to 36 months after the index procedure
Pseudoaneurysm at the treatment sites
Individual rate of the pseudoaneurysm at the treatment sites
Time frame: 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
Time frame: Up to 36 months after the index procedure
Late Type I endoleak
Individual rate of the Type I endoleak confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Late Type III endoleak
Individual rate of the Type III endoleak confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Non-cardiac/non-aortic re-operations
Individual rate of non-cardiac/non-aortic re-operations
Time frame: Up to 36 months after the index procedure
Vocal Cord paralysis
Individual rate of vocal cord paralysis
Time frame: Up to 36 months after the index procedure
Myocardial infarction
Individual rate of myocardial infarction
Time frame: Up to 36 months after the index procedure
Respiratory failure
Individual rate of respiratory failure
Time frame: Up to 36 months after the index procedure
Renal failure requiring dialysis
Individual rate of renal failure requiring dialysis
Time frame: Up to 36 months after the index procedure
Thromboembolic events
Individual rate of thromboembolic events
Time frame: 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)
Time frame: 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
Time frame: Up to 36 months after the index procedure
Aortic rupture
Individual rate of aortic rupture
Time frame: Up to 36 months after the index procedure
Device integrity failures
Individual rate of device integrity failures confirmed by CT imaging assessment
Time frame: Up to 36 months after the index procedure
Device crimping/kinking
Individual rate of device crimping/kinking confirmed by CT imaging assessment
Time frame: 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
Time frame: 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
Time frame: Up to 36 months after the index procedure
Surgical graft/stentgraft infection
Individual rate of surgical graft/stentgraft infection
Time frame: Up to 36 months after the index procedure
Incidence of all endoleak types
Individual rate of all endoleak types confirmed by CT imaging assessment
Time frame: 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
Time frame: Up to 36 months after the index procedure
Non-serious and serious adverse events
Individual rate of non-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
Individual rate of the extension device integrity issues confirmed by CT imaging assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 36 months after the index procedure
Incidence of secondary procedures related to the extension
Individual rate secondary procedures related to the extension
Time frame: Up to 36 months after the index procedure
Plan to share: No
Started Mar 2021 (actual). Primary completion is estimated for Dec 2030, 117 months after the start.
Of 28 interventional studies with no phase under Aortic Aneurysm, Thoracic, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 107. This study's planned 117 months is above that.
How these figures are worked out, and which studies are left out of them.
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