B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Aortic Dissection Clinical Trial

— B-SAFER  

Official title:

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747626
• Other study ID #: G200342
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Eric Roselli, M. D.
• Phone: 216-444-0995
• Email: roselle[@]ccf.rg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Dissection
• Congenital Aortic Anomaly
• Thoracic Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Eric Roselli, M. D.	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Individual rate of occurrence of the death from all-cause	Up to 30 days
Primary	Stroke, excluding TIA	Individual rate of occurrence of stroke	Up to 30 days
Primary	Paralysis, excluding paraparesis	Individual rate of occurrence of paralysis	Up to 30 days
Primary	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
Primary	Patency of all graft/endograft components	Patent graft/endografts confirmed by CT imaging assessment	At hospital discharge or at 1 month
Primary	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	Aortic related death	Individual rate of the aortic related death	Up to 36 months after the index procedure
Secondary	Pseudoaneurysm at the treatment sites	Individual rate of the pseudoaneurysm at the treatment sites	Up to 36 months after the index procedure
Secondary	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
Secondary	Late Type I endoleak	Individual rate of the Type I endoleak confirmed by CT imaging assessment	Up to 36 months after the index procedure
Secondary	Late Type III endoleak	Individual rate of the Type III endoleak confirmed by CT imaging assessment	Up to 36 months after the index procedure
Secondary	Non-cardiac/non-aortic re-operations	Individual rate of non-cardiac/non-aortic re-operations	Up to 36 months after the index procedure
Secondary	Vocal Cord paralysis	Individual rate of vocal cord paralysis	Up to 36 months after the index procedure
Secondary	Myocardial infarction	Individual rate of myocardial infarction	Up to 36 months after the index procedure
Secondary	Respiratory failure	Individual rate of respiratory failure	Up to 36 months after the index procedure
Secondary	Renal failure requiring dialysis	Individual rate of renal failure requiring dialysis	Up to 36 months after the index procedure
Secondary	Thromboembolic events	Individual rate of thromboembolic events	Up to 36 months after the index procedure
Secondary	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	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
Secondary	Aortic rupture	Individual rate of aortic rupture	Up to 36 months after the index procedure
Secondary	Device integrity failures	Individual rate of device integrity failures confirmed by CT imaging assessment	Up to 36 months after the index procedure
Secondary	Device crimping/kinking	Individual rate of device crimping/kinking confirmed by CT imaging assessment	Up to 36 months after the index procedure
Secondary	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
Secondary	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
Secondary	Surgical graft/stentgraft infection	Individual rate of surgical graft/stentgraft infection	Up to 36 months after the index procedure
Secondary	Incidence of all endoleak types	Individual rate of all endoleak types confirmed by CT imaging assessment	Up to 36 months after the index procedure
Secondary	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
Secondary	Non-serious and serious adverse events	Individual rate of non-serious adverse events	Up to 36 months after the index procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of secondary procedures related to the extension	Individual rate secondary procedures related to the extension	Up to 36 months after the index procedure