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Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Primary Purpose

Thoracoabdominal Aortic Aneurysm

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Zenith® t-Branch

About this trial

This is an interventional treatment trial for Thoracoabdominal Aortic Aneurysm focused on measuring Aortic Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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

Exclusion Criteria

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)
Inability to insert the Zenith® t-Branch device through iliofemoral approach
Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
Proximal landing zone length <25mm to allow secure fixation and seal
Proximal landing zone diameter of <24mm or >42mm
Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Treatment Arm

Arm Description

All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Outcomes

Primary Outcome Measures

Early Mortality

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01524211

First Posted

January 30, 2012

Last Updated

February 20, 2023

Sponsor

Lee, W. Anthony, M.D. FACS

Collaborators

William Cook Australia

1. Study Identification

Unique Protocol Identification Number

NCT01524211

Brief Title

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Official Title

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2012 (Actual)

Primary Completion Date

December 2031 (Anticipated)

Study Completion Date

January 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lee, W. Anthony, M.D. FACS

Collaborators

William Cook Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.

Detailed Description

Study Update as of 2/20/2023;159 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracoabdominal Aortic Aneurysm

Keywords

Aortic Aneurysms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All eligible subjects will receive treatment with the investigational t-Branch Endovascular Graft

Masking

None (Open Label)

Allocation

N/A

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Treatment Arm

Arm Type

Experimental

Arm Description

All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.

Intervention Type

Device

Intervention Name(s)

Zenith® t-Branch

Intervention Description

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.

Primary Outcome Measure Information:

Title

Early Mortality

Description

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

Time Frame

30 days post implant of the branch endografts

Secondary Outcome Measure Information:

Title

Rates of Neurologic Complications/Late Branch Vessel Patency

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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 Exclusion Criteria 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) Inability to insert the Zenith® t-Branch device through iliofemoral approach Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm Proximal landing zone length <25mm to allow secure fixation and seal Proximal landing zone diameter of <24mm or >42mm Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisamarie Kernicky, RN;BSN;CCRC

Phone

561-955-5239

lkernicky@brrh.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

W. Anthony Lee, MD

Organizational Affiliation

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisamarie Kernicky, RN;BSN;CCRC

Phone

561-955-5239

lkernicky@brrh.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

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