Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

NCT01524211 | Recruiting FDA Device

• 1 other identifier: IDE G110081
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracoabdominal Aortic Aneurysm; Aortic Arch Aneurysm

Keywords

Aortic Aneurysms

Outcome Measures

Primary Outcomes (1)

• Early Mortality & Stroke

  The primary aim of this study is to determine the rate of early mortality and stroke after branch endograft treatment.

  30 days post implant of the branch endografts

Secondary Outcomes (1)

• Rates of Neurologic Complications/Late Branch Vessel Patency

  Day 0-Day 30 (Early) Day 31-1825 (Late)

Study Arms (2)

Single Treatment Arm-Zenith t-Branch Cohort

EXPERIMENTAL

Zenith t-Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Device: Zenith® t-Branch

Single Treatment Arm-Terumo Arch Branch Cohort

EXPERIMENTAL

Terumo Arch Branch Cohort:Those subjects eligible for enrollment will receive endovascular treatment with the investigational Terumo Arch Branch Endovascular Graft.

Device: Terumo Arch Branch

Interventions

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.

Single Treatment Arm-Zenith t-Branch Cohort

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.

Single Treatment Arm-Terumo Arch Branch Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have one of the following:
• 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
• Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.
• Additional criteria for LP material
• Iliofemoral access vessels \<8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator

You may not qualify if:

• General Criteria
• 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
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized
• Medical Criteria
• Uncontrolled systemic infection
• Untreatable malignancy
• Uncontrollable anaphylaxis to iodinated contrast
• Known allergy(ies) to device materials
• Anatomic Criteria
• Any pathology of mycotic origin
• Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)

Sponsors & Collaborators

• Baptist Health South Florida: lead
• William Cook Australia: collaborator
• Bolton Medical: collaborator

Study Sites (1)

Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)

Boca Raton, Florida, 33486, United States

RECRUITING

Related Publications (1)

• Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.

  PMID: 37330702 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aneurysm, Aortic Arch; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Officials

• W. Anthony Lee, MD

  Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisamarie Kernicky, RN;BSN;CCRC

CONTACT

561-955-5239; lkernicky@brrh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Zenith t-Branch Subject Cohort: All eligible subjects will receive treatment with the investigational t-Branch Endovascular Graft. (Total 225 subjects) Terumo Arch Branch Cohort: All eligible subjects will receive treatment with the investigational Terumo Arch Branch Endovascular Graft. (Total 10 Subjects)

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: January 25, 2012
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)