Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Not Applicable

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm; Aortic Arch Aneurysm
• Interventions: Device: Zenith® t-Branch; Device: Terumo Arch Branch

• Registration Number: NCT01524211
• Lead Sponsor: Baptist Health South Florida

Brief Summary

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.

Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.

Detailed Description

Study Update as of 5/31/2024; 179 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing. Arch Branch Subject Cohort enrollment is open.

Study Timeline

• Study Start: 2012-01-25
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2031-12
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Treatment Arm-Zenith t-Branch Cohort	Zenith® t-Branch	Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
Single Treatment Arm-Terumo Arch Branch Cohort	Terumo Arch Branch	Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft.

Primary Outcome Measures

Name	Time	Method
Early Mortality & Stroke	30 days post implant of the branch endografts	The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.

Secondary Outcome Measures

Name	Time	Method
Rates of Neurologic Complications/Late Branch Vessel Patency	Day 0-Day 30 (Early) Day 31-1825 (Late)	The secondary aims of this study are to determine the rates of neurologic complications and late branch/target vessel patency, type I and III endoleaks and secondary interventions after branch endograft treatment. In those subjects enrolled in the t-Branch cohort we will evaluate the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms.

Trial Locations

Locations (1)

Baptist Health South Florida|Boca Raton Regional Hospital (BRRH); 🇺🇸 Boca Raton, Florida, United States