Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm; Aortic Arch Aneurysm
• Intervention / Treatment: Device: Zenith® t-Branch

Detailed Description

Study Update:

As of 1/22/2024;174 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisamarie Kernicky, RN;BSN;CCRC; Phone Number: 561-955-5239; Email: lkernicky@brrh.com

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
      • Contact: Lisamarie Kernicky, RN;BSN;CCRC; Phone Number: 561-955-5239; Email: lkernicky@brrh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

The patient must have one of the following:

1. 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
2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
3. Penetrating ulcers: ≥20mm in depth or
4. Chronic type B aortic dissections: ≥50mm total aortic diameter or
5. 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

Exclusion Criteria

General Criteria

1. Life-expectancy less than 12 months
2. Refusal to receive blood products
3. Age <18 years
4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
5. Unwilling to comply with the follow-up schedule
6. Inability or refusal to give informed consent by subject and/or Legally Authorized Representative (LAR); should one be utilized

Medical Criteria

1. Uncontrolled systemic infection
2. Untreatable malignancy
3. Uncontrollable anaphylaxis to iodinated contrast
4. Known allergy(ies) to device materials

Anatomic Criteria

1. Any pathology of mycotic origin
2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
3. Inability to insert the Zenith® t-Branch device through iliofemoral approach
4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
5. Proximal landing zone length <25mm to allow secure fixation and seal
6. Proximal landing zone diameter of <24mm or >42mm
7. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
8. Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Treatment Arm; All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Device: Zenith® t-Branch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Mortality	The primary aim of this study is to determine the rate of early mortality after branch endograft treatment.	30 days post implant of the branch endografts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 vessel patency after branch endograft treatment, and the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms	Day 0-Day 30 (Early) Day 31-1825 (Late)

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Collaborators: William Cook Australia
• Investigators: Principal Investigator: W. Anthony Lee, MD, Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2012
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimated): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Aneurysms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal; Aneurysm, Aortic Arch
• Other Study ID Numbers: IDE G110081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes