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NCT01524211
Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Conditions: Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 235
Sponsor: Baptist Health South Florida
Location: Baptist Health South Florida|Boca Raton Regional Hospital (BRRH) Boca Raton Florida
Summary
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.
Eligibility Criteria
Zenith t-Branch Eligibility Criteria:
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 \
Source: ClinicalTrials.gov (NCT01524211). StuddyBuddy aggregates publicly available trial information.