Actively Recruiting
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
1040 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
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.
CONDITIONS
Official Title
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of degenerative, atherosclerotic thoracoabdominal, suprarenal, or juxtarenal aortic aneurysms 55mm or larger in diameter for males, or 50mm or larger for females
- Thoracoabdominal aortic aneurysm with growth of 0.5 cm or more per year
- Penetrating ulcers 20mm or deeper
- Chronic type B aortic dissections with total aortic diameter 50mm or larger
- Symptomatic aneurysm, ulcer, or chronic dissection of any size
- For Terumo Arch Branch, degenerative aneurysm involving ascending aorta, aortic arch, or proximal descending aorta 55mm or larger, or over 50mm with growth of 5mm or more in last 6 months
- Patients considered high-risk or prohibitive for open surgical repair due to conditions such as age over 85, prior sternotomy, severe aortic calcification, severe occlusive disease of arch vessels, moderate to severe COPD, severe chronic kidney disease, left ventricular dysfunction, chronic steroid or immunosuppressive use, increased bleeding risk, or neurocognitive or musculoskeletal deficits impacting rehabilitation
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 comply with follow-up schedule or give informed consent
- Uncontrolled systemic infection
- Untreatable malignancy
- Uncontrollable anaphylaxis to iodinated contrast
- Known allergy to device materials
- Aortic pathologies of mycotic origin
- Aortic fistulous connections with non-vascular structures
- Inability to insert device through iliofemoral approach
- Proximal or distal landing zones too short or outside specified diameter ranges
- For Terumo Arch Branch: pending cardiac surgery, severe symptomatic coronary or valvular disease, prior mechanical aortic valve replacement, history of transcatheter aortic valve replacement, severe calcific aortic stenosis, acute or type A aortic dissection, symptomatic or ruptured pathology, unsuitable anatomy for repair with available endografts, untreated severe carotid stenosis, ascending aortic angulation less than 15mm radius, and various branch vessel size restrictions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
Boca Raton, Florida, United States, 33486
Actively Recruiting
Research Team
L
Lisamarie Kernicky, RN;BSN;CCRC
CONTACT
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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