Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Recruiting now · Not applicable

Conditions studied: Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm

In brief

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.

Key facts

Study ID

NCT01524211

Run by

Baptist Health South Florida

People needed

235

Starts

2012-01-25

Expected to finish

2032-01-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Terumo Arch Branch Eligibility Criteria
• Inclusion Criteria
• The subject must have one of the following:
• Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or > 50 mm with a history of growth ≥5 mm in the last 6 months, or

Where it is running

• Baptist Health South Florida|Boca Raton Regional Hospital (BRRH) — Boca Raton, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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