Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Thoracoabdominal Aortic Aneurysm Clinical Trial

Official title:

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524211
• Other study ID #: IDE G110081
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2012
• Est. completion date: January 2032

Study information

• Verified date: October 2023
• Source: Baptist Health South Florida
• Contact: Lisamarie Kernicky, RN;BSN;CCRC
• Phone: 561-955-5239
• Email: lkernicky[@]brrh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: January 2032
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracoabdominal
• Aortic Arch Aneurysm
• Thoracoabdominal Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
United States	Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)	Boca Raton	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	William Cook Australia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)