Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

ConditionsThoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBaptist Health South Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or

Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or

Penetrating ulcers: ≥20mm in depth or

Chronic type B aortic dissections: ≥50mm total aortic diameter or

Disqualifiers

Life-expectancy less than 12 months

Refusal to receive blood products

Age <18 years

Pregnant or breastfeeding or planning on becoming pregnant within 60 months

Trial design

Design model

Single group

Treatments tested in this trial

Zenith® t-Branch
Device
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.
Terumo Arch Branch
Device
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.

Treatment groups

235 Participants

are divided into 2 treatment groups

Group A: Single Treatment Arm-Zenith t-Branch CohortExperimental treatment 1 intervention

Group B: Single Treatment Arm-Terumo Arch Branch CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Early 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

Secondary outcomes

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)

Sponsors and contacts

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Baptist Health South Florida

Lead sponsor

William Cook Australia

Collaborator

Bolton Medical