Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Conditions

• Aortic Arch Aneurysm
• Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jan 25, 2012

Status verified

Jun 2025

Primary completion

Dec 31, 2031

Completion

Jan 31, 2032

Study Design

Enrollment

235 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Early Mortality & Stroke [ Time Frame: 30 days post implant of the branch endografts ]

Central Contacts

• Lisamarie Kernicky, RN;BSN;CCRC
  561-955-5239
  [email protected]

Locations (1)

Find similar trials in Boca Raton, FL

Related Studies

• PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
  Recruiting · Konstantinos Dean Arnaoutakis, MD · Tampa, Florida
• GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
  Recruiting · W.L.Gore & Associates · Gainesville, Florida
• Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
  Recruiting · Warren J. Gasper, MD · San Francisco, California
• Endovascular Treatment of Thoracic Aortic Disease
  Enrolling By Invitation · Matthew Eagleton · Boston, Massachusetts