Clinical trial NCT04747626: B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Official title: B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Aortic Aneurysm
Aortic Dissection
Congenital Aortic Anomaly
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2021-02-10
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: Up to 30 days
measure: Stroke, excluding TIA
timeFrame: Up to 30 days
measure: Paralysis, excluding paraparesis
timeFrame: Up to 30 days
measure: Technical success
timeFrame: 24 hours
measure: Patency of all graft/endograft components
timeFrame: At hospital discharge or at 1 month
measure: Complete sealing of the aortic pathology
timeFrame: At hospital discharge or 1 month
Secondary outcomes:
measure: Aortic related death
timeFrame: Up to 36 months after the index procedure
measure: Pseudoaneurysm at the treatment sites
timeFrame: Up to 36 months after the index procedure
measure: Unanticipated aortic or branch-related re-operation
timeFrame: Up to 36 months after the index procedure
measure: Late Type I endoleak
timeFrame: Up to 36 months after the index procedure
measure: Late Type III endoleak
timeFrame: Up to 36 months after the index procedure
measure: Non-cardiac/non-aortic re-operations
timeFrame: Up to 36 months after the index procedure
measure: Vocal Cord paralysis
timeFrame: Up to 36 months after the index procedure
measure: Myocardial infarction
timeFrame: Up to 36 months after the index procedure
measure: Respiratory failure
timeFrame: Up to 36 months after the index procedure
measure: Renal failure requiring dialysis
timeFrame: Up to 36 months after the index procedure
measure: Thromboembolic events
timeFrame: Up to 36 months after the index procedure
measure: Failed patencies in graft, or endovascular stent-graft including the branch(es)
timeFrame: Up to 36 months after the index procedure
measure: Secondary unplanned interventions in the treated vascular segment or related to the original pathology
timeFrame: Up to 36 months after the index procedure
measure: Aortic rupture
timeFrame: Up to 36 months after the index procedure
measure: Device integrity failures
timeFrame: Up to 36 months after the index procedure
measure: Device crimping/kinking
timeFrame: Up to 36 months after the index procedure
measure: Device migration
timeFrame: Up to 36 months after the index procedure
measure: Thrombosis of the device lumen
timeFrame: Up to 36 months after the index procedure
measure: Surgical graft/stentgraft infection
timeFrame: Up to 36 months after the index procedure
measure: Incidence of all endoleak types
timeFrame: Up to 36 months after the index procedure
measure: Migration of the distal extension
timeFrame: Up to 36 months after the index procedure
measure: Non-serious and serious adverse events
timeFrame: Up to 36 months after the index procedure
measure: Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device
timeFrame: Up to 36 months after the index procedure
measure: Incidence of Type III endoleak related to the extension device
timeFrame: Up to 36 months after the index procedure
measure: Incidence of failed patency of the device-extension overlap
timeFrame: Up to 36 months after the index procedure
measure: Incidence of MAE at 30 days post-extension
timeFrame: Up to 36 months after the index procedure
measure: Incidence of secondary procedures related to the extension
timeFrame: Up to 36 months after the index procedure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Eric Roselli, M. D.
role: PRINCIPAL_INVESTIGATOR
References: