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

Primary Purpose

Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

B-SAFER

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Outcomes

Primary Outcome Measures

All-cause mortality

Individual rate of occurrence of the death from all-cause

Stroke, excluding TIA

Individual rate of occurrence of stroke

Paralysis, excluding paraparesis

Individual rate of occurrence of paralysis

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

Patency of all graft/endograft components

Patent graft/endografts confirmed by CT imaging assessment

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

Secondary Outcome Measures

Aortic related death

Individual rate of the aortic related death

Pseudoaneurysm at the treatment sites

Individual rate of the pseudoaneurysm at the treatment sites

Unanticipated aortic or branch-related re-operation

Individual rate of the unanticipated aortic or branch-related re-operation

Late Type I endoleak

Individual rate of the Type I endoleak confirmed by CT imaging assessment

Late Type III endoleak

Individual rate of the Type III endoleak confirmed by CT imaging assessment

Non-cardiac/non-aortic re-operations

Individual rate of non-cardiac/non-aortic re-operations

Vocal Cord paralysis

Individual rate of vocal cord paralysis

Myocardial infarction

Individual rate of myocardial infarction

Respiratory failure

Individual rate of respiratory failure

Renal failure requiring dialysis

Individual rate of renal failure requiring dialysis

Thromboembolic events

Individual rate of thromboembolic events

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)

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

Aortic rupture

Individual rate of aortic rupture

Device integrity failures

Individual rate of device integrity failures confirmed by CT imaging assessment

Device crimping/kinking

Individual rate of device crimping/kinking confirmed by CT imaging assessment

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

Thrombosis of the device lumen

Individual rate of thrombosis of the device lumen confirmed by CT imaging assessment

Surgical graft/stentgraft infection

Individual rate of surgical graft/stentgraft infection

Incidence of all endoleak types

Individual rate of all endoleak types confirmed by CT imaging assessment

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

Non-serious and serious adverse events

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

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

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

Incidence of failed patency of the device-extension overlap

Individual rate of failed patency of the device-extension overlap confirmed by CT imaging assessment

Incidence of MAE at 30 days post-extension

Individual rate and type of MAE at 30 days post-extension

Incidence of secondary procedures related to the extension

Individual rate secondary procedures related to the extension

Full Information

NCT ID

NCT04747626

First Posted

February 5, 2021

Last Updated

April 19, 2023

Sponsor

Eric Roselli, M. D.

Collaborators

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04747626

Brief Title

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Acronym

B-SAFER

Official Title

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2021 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eric Roselli, M. D.

Collaborators

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Intervention Type

Device

Intervention Name(s)

B-SAFER

Intervention Description

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.

Primary Outcome Measure Information:

Title

All-cause mortality

Description

Individual rate of occurrence of the death from all-cause

Time Frame

Up to 30 days

Title

Stroke, excluding TIA

Description

Individual rate of occurrence of stroke

Time Frame

Up to 30 days

Title

Paralysis, excluding paraparesis

Description

Individual rate of occurrence of paralysis

Time Frame

Up to 30 days

Title

Technical success

Description

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

Time Frame

24 hours

Title

Patency of all graft/endograft components

Description

Patent graft/endografts confirmed by CT imaging assessment

Time Frame

At hospital discharge or at 1 month

Title

Complete sealing of the aortic pathology

Description

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

Time Frame

At hospital discharge or 1 month

Secondary Outcome Measure Information:

Title

Aortic related death

Description

Individual rate of the aortic related death

Time Frame