Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair.
Eric J Finnesgard, Adam W Beck, Matthew J Eagleton...
https://pubmed.ncbi.nlm.nih.gov/37330702Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID01524211
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Led by Baptist Health South Florida · Updated on 2025-06-06
235
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
W
William Cook Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two branch endograft devices, the Zenith t-Branch and the Terumo Arch Branch, for treating aortic aneurysms affecting the thoracoabdominal area and aortic arch. The study aims to collect detailed information on the performance and safety of these devices, especially for cases where conventional thoracic endografts are not suitable. This clinical trial is ongoing and sponsored by Baptist Health South Florida. Participants receive endovascular treatment using one of the investigational devices depending on their aneurysm type. The Zenith t-Branch is a tubular graft with four branches designed to maintain blood flow to key visceral arteries, while the Terumo Arch Branch is a custom-made graft intended for proximal thoracic aortic conditions. Both devices are inserted through iliofemoral access during the procedures. Participants will be monitored for early mortality and stroke within 30 days after device implantation, along with neurological complications and branch vessel patency over a longer period of up to five years. The study includes regular follow-ups to assess device performance and patient outcomes. Recruitment is ongoing, and over 180 subjects have been implanted with the Zenith t-Branch device to date.
CONDITIONS
Brief Title
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with degenerative, atherosclerotic thoracoabdominal, suprarenal, or juxtarenal aortic aneurysms 55mm or larger in males or 50mm or larger in females, or
- Aneurysm with growth of 0.5 cm or more per year, or
- Penetrating ulcers 20mm or deeper, or
- Chronic type B aortic dissections 50mm or larger, or
- Symptomatic aneurysm, ulcer, or chronic dissection of any size
- For Terumo Arch Branch: aneurysm involving ascending aorta, arch, or proximal descending aorta 55mm or larger, or larger than 50mm with recent growth
- High-risk or prohibitive for open surgical repair due to pre-existing conditions such as age over 85, prior surgeries, severe calcification, or lung and kidney disease
- Willingness to comply with follow-up schedule
You will not qualify if you...
- Life expectancy less than 12 months
- Refusal to receive blood products
- Age under 18 years
- Pregnant, breastfeeding, or planning pregnancy within 60 months
- Unwillingness or inability to give informed consent or comply with follow-up
- Uncontrolled systemic infection or untreatable cancer
- Known allergy to device materials
- Aortic pathology of mycotic origin or fistulous communication
- Inability to insert the device through iliofemoral access
- Proximal or distal landing zones with unsuitable length or diameter
- For Terumo Arch Branch: pending cardiac surgery, severe heart valve conditions, prior mechanical valve, severe carotid stenosis, or unsuitable aortic anatomy
- Symptomatic or ruptured pathology
- Anatomy suitable for repair with commercially available grafts
- Willingness to travel for participation if required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day 0 (procedure day)
Participants receive endovascular treatment with the investigational branch endograft device to repair their aortic aneurysms.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 5 years (Day 1 to Day 1825)
Participants are monitored for early mortality, stroke, neurologic complications, and late branch vessel patency after the implant procedure.
Regular follow-up visits up to 5 years
Trial Site Locations
Total: 1 location
1
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, United States, 33486
Actively Recruiting
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Research Team
L
Lisamarie Kernicky, RN;BSN;CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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