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.
Study Update as of 3/31/2025; 186 subjects successfully have been implanted with the Zenith t-Branch Device and 1 subject has been implanted with the Arch Branch to date and recruitment is ongoing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
235
The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.
The Arch Branch endograft is a custom-made endograft based on the Relay thoracic stent graft platform. The device is intended to land proximally in the ascending aorta just distal to the sinotubular junction, and distally either in the native thoracic aorta for focal arch pathologies, or more extensive pathologies either extended with another commercially available thoracic endograft or mated to a pre-existing thoracic endograft, which would serve as a distal landing zone. It is constructed of polyester graft material (same as those used for the Terumo Relay Plus or Pro) sewn to self-expanding nitinol stents with suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the stents provide the necessary attachment and seal of the graft to the aortic wall.
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, United States
RECRUITINGEarly Mortality & Stroke
The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.
Time frame: 30 days post implant of the branch endografts
Rates of Neurologic Complications/Late Branch Vessel Patency
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.
Time frame: Day 0-Day 30 (Early) Day 31-1825 (Late)
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