B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
- Conditions
- Aortic DissectionCongenital Aortic AnomalyThoracic Aortic Aneurysm
- Interventions
- Device: B-SAFER
- Registration Number
- NCT04747626
- Lead Sponsor
- Eric Roselli, M. D.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 490
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment B-SAFER Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.
- Primary Outcome Measures
Name Time Method All-cause mortality Up to 30 days Individual rate of occurrence of the death from all-cause
Stroke, excluding TIA Up to 30 days Individual rate of occurrence of stroke
Technical success 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 At hospital discharge or at 1 month Patent graft/endografts confirmed by CT imaging assessment
Complete sealing of the aortic pathology 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
Paralysis, excluding paraparesis Up to 30 days Individual rate of occurrence of paralysis
- Secondary Outcome Measures
Name Time Method Device migration 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
Incidence of Type III endoleak related to the extension device 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
Thromboembolic events Up to 36 months after the index procedure Individual rate of thromboembolic events
Incidence of all endoleak types Up to 36 months after the index procedure Individual rate of all endoleak types confirmed by CT imaging assessment
Migration of the distal extension 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
Non-serious and serious adverse events Up to 36 months after the index procedure Individual rate of non-serious adverse events
Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device Up to 36 months after the index procedure Individual rate of the extension device integrity issues confirmed by CT imaging assessment
Incidence of failed patency of the device-extension overlap Up to 36 months after the index procedure Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment
Incidence of MAE at 30 days post-extension Up to 36 months after the index procedure Individual rate and type of MAE at 30 days post-extension
Incidence of secondary procedures related to the extension Up to 36 months after the index procedure Individual rate secondary procedures related to the extension
Aortic related death Up to 36 months after the index procedure Individual rate of the aortic related death
Renal failure requiring dialysis Up to 36 months after the index procedure Individual rate of renal failure requiring dialysis
Pseudoaneurysm at the treatment sites Up to 36 months after the index procedure Individual rate of the pseudoaneurysm at the treatment sites
Device crimping/kinking Up to 36 months after the index procedure Individual rate of device crimping/kinking confirmed by CT imaging assessment
Aortic rupture Up to 36 months after the index procedure Individual rate of aortic rupture
Device integrity failures Up to 36 months after the index procedure Individual rate of device integrity failures confirmed by CT imaging assessment
Late Type I endoleak Up to 36 months after the index procedure Individual rate of the Type I endoleak confirmed by CT imaging assessment
Late Type III endoleak Up to 36 months after the index procedure Individual rate of the Type III endoleak confirmed by CT imaging assessment
Non-cardiac/non-aortic re-operations Up to 36 months after the index procedure Individual rate of non-cardiac/non-aortic re-operations
Vocal Cord paralysis Up to 36 months after the index procedure Individual rate of vocal cord paralysis
Myocardial infarction Up to 36 months after the index procedure Individual rate of myocardial infarction
Respiratory failure Up to 36 months after the index procedure Individual rate of respiratory failure
Failed patencies in graft, or endovascular stent-graft including the branch(es) Up to 36 months after the index procedure Individual rate of failed patencies in gaft or endovascular stent-graft including branch(es)
Secondary unplanned interventions in the treated vascular segment or related to the original pathology 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
Thrombosis of the device lumen Up to 36 months after the index procedure Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment
Surgical graft/stentgraft infection Up to 36 months after the index procedure Individual rate of surgical graft/stentgraft infection
Unanticipated aortic or branch-related re-operation Up to 36 months after the index procedure Individual rate of the unanticipated aortic or branch-related re-operation
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States