B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Conditions
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Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly

Intervention / Treatment
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* Device: B-SAFER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments. | Device: B-SAFER<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic related death | Individual rate of the aortic related death | Up to 36 months after the index procedure | 
| Pseudoaneurysm at the treatment sites | Individual rate of the pseudoaneurysm at the treatment sites | 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 | Up to 36 months after the index procedure | 
| Late Type I endoleak | Individual rate of the Type I endoleak confirmed by CT imaging assessment | Up to 36 months after the index procedure | 
| Late Type III endoleak | 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 | Individual rate of non-cardiac/non-aortic re-operations | Up to 36 months after the index procedure | 
| Vocal Cord paralysis | Individual rate of vocal cord paralysis | Up to 36 months after the index procedure | 
| Myocardial infarction | Individual rate of myocardial infarction | Up to 36 months after the index procedure | 
| Respiratory failure | Individual rate of respiratory failure | Up to 36 months after the index procedure | 
| Renal failure requiring dialysis | Individual rate of renal failure requiring dialysis | Up to 36 months after the index procedure | 
| Thromboembolic events | 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) | 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 | 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 | Individual rate of aortic rupture | Up to 36 months after the index procedure | 
| Device integrity failures | Individual rate of device integrity failures confirmed by CT imaging assessment | Up to 36 months after the index procedure | 
| Device crimping/kinking | Individual rate of device crimping/kinking confirmed by CT imaging assessment | 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 | 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 | Up to 36 months after the index procedure | 
| Surgical graft/stentgraft infection | Individual rate of surgical graft/stentgraft infection | Up to 36 months after the index procedure | 
| Incidence of all endoleak types | Individual rate of all endoleak types confirmed by CT imaging assessment | 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 | Up to 36 months after the index procedure | 
| Non-serious and serious adverse events | 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 | 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 | 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 | 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 | 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 | Individual rate secondary procedures related to the extension | Up to 36 months after the index procedure |