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B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER)

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ClinicalTrials.gov Identifier: NCT04747626
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Eric Roselli, M. D., The Cleveland Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Aortic Dissection Congenital Aortic Anomaly Device: B-SAFER Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to 30 days ]
    Individual rate of occurrence of the death from all-cause

  2. Stroke, excluding TIA [ Time Frame: Up to 30 days ]
    Individual rate of occurrence of stroke

  3. Paralysis, excluding paraparesis [ Time Frame: Up to 30 days ]
    Individual rate of occurrence of paralysis

  4. 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

  5. Patency of all graft/endograft components [ Time Frame: At hospital discharge or at 1 month ]
    Patent graft/endografts confirmed by CT imaging assessment

  6. 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


Secondary Outcome Measures :
  1. Aortic related death [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of the aortic related death

  2. Pseudoaneurysm at the treatment sites [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of the pseudoaneurysm at the treatment sites

  3. Unanticipated aortic or branch-related re-operation [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of the unanticipated aortic or branch-related re-operation

  4. Late Type I endoleak [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of the Type I endoleak confirmed by CT imaging assessment

  5. Late Type III endoleak [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of the Type III endoleak confirmed by CT imaging assessment

  6. Non-cardiac/non-aortic re-operations [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of non-cardiac/non-aortic re-operations

  7. Vocal Cord paralysis [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of vocal cord paralysis

  8. Myocardial infarction [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of myocardial infarction

  9. Respiratory failure [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of respiratory failure

  10. Renal failure requiring dialysis [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of renal failure requiring dialysis

  11. Thromboembolic events [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of thromboembolic events

  12. Failed patencies in graft, or endovascular stent-graft including the branch(es) [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of failed patencies in gaft or endovascular stent-graft including branch(es)

  13. Secondary unplanned interventions in the treated vascular segment or related to the original pathology [ Time Frame: 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

  14. Aortic rupture [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of aortic rupture

  15. Device integrity failures [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of device integrity failures confirmed by CT imaging assessment

  16. Device crimping/kinking [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of device crimping/kinking confirmed by CT imaging assessment

  17. Device migration [ Time Frame: 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

  18. Thrombosis of the device lumen [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment

  19. Surgical graft/stentgraft infection [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of surgical graft/stentgraft infection

  20. Incidence of all endoleak types [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of all endoleak types confirmed by CT imaging assessment

  21. Migration of the distal extension [ Time Frame: 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

  22. Non-serious and serious adverse events [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of non-serious adverse events

  23. 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 ]
    Individual rate of the extension device integrity issues confirmed by CT imaging assessment

  24. Incidence of Type III endoleak related to the extension device [ Time Frame: 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

  25. Incidence of failed patency of the device-extension overlap [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment

  26. Incidence of MAE at 30 days post-extension [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate and type of MAE at 30 days post-extension

  27. Incidence of secondary procedures related to the extension [ Time Frame: Up to 36 months after the index procedure ]
    Individual rate secondary procedures related to the extension


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747626


Contacts
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Contact: Eric Roselli, M. D. 216-444-0995 roselle@ccf.rg
Contact: Yuki Kuramochi, BSN, RN 2164454063 kuramoy@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Eric Roselli, M. D.    216-444-0995    roselle@ccf.org   
Contact: Yuki Kuramochi, BSN, RN    216-445-4063    kuramoy@ccf.org   
Principal Investigator: Eric Roselli, M. D.         
Sub-Investigator: Douglas Johnston, M. D.         
Sub-Investigator: Faisal Bakaeen, M. D.         
Sub-Investigator: Patrick Vargo, M. D.         
Sub-Investigator: Daniel Burns, M. D.         
Sub-Investigator: Edward Soltez, M. D.         
Sub-Investigator: Michael Tong, M. D.         
Sub-Investigator: Shinya Unai, M. D.         
Sub-Investigator: Haytham Elgharably, M. D.         
Sub-Investigator: Francis Caputo, M. D.         
Sub-Investigator: Christopher Smolock, M. D.         
Sub-Investigator: Jared Rowse, M. D.         
Sub-Investigator: Lee Kirksey, M. D.         
Sub-Investigator: John Quatromoni, M. D.         
Sponsors and Collaborators
Eric Roselli, M. D.
The Cleveland Clinic
Investigators
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Principal Investigator: Eric Roselli, M. D. The Cleveland Clinic
More Information
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Responsible Party: Eric Roselli, M. D., Sponsor/Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04747626    
Other Study ID Numbers: G200342
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases