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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection; Thoracic Aortic Aneurysm; Congenital Aortic Anomaly
• Intervention / Treatment: Device: B-SAFER

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 Type: Interventional
• Enrollment (Estimated): 590
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Roselli, M. D.; Phone Number: 216-444-0995; Email: roselle@ccf.rg
• Study Contact Backup: Name: Yuki Kuramochi, BSN, RN; Phone Number: 2164454063; Email: kuramoy@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Eric Roselli, M. D.; Phone Number: 216-444-0995; Email: roselle@ccf.org
      • Contact: Yuki Kuramochi, BSN, RN; Phone Number: 216-445-4063; Email: kuramoy@ccf.org
      • Principal Investigator: Eric Roselli, M. D.
      • Sub-Investigator: Faisal Bakaeen, M. D.
      • Sub-Investigator: Patrick Vargo, 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: Lee Kirksey, M. D.
      • Sub-Investigator: John Quatromoni, M. D.
      • Sub-Investigator: Marc Gillinov, M. D.
      • Sub-Investigator: Marijan Koprivanac, M. D.
      • Sub-Investigator: Sean Steenberge, M. D.
      • Sub-Investigator: Ali Khalifeh, M. D.
      • Sub-Investigator: Ravi Ambani, M. D.
      • Sub-Investigator: Anthony Zaki, M. D.
      • Sub-Investigator: Tarek Malas, M. D.
      • Sub-Investigator: Xiaoying Lou, M. D.
      • Sub-Investigator: Donna Kilmmaliardjuk, M. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eric Roselli, M. D.
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Eric Roselli, M. D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: G200342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No