Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Completed · Not applicable
Conditions studied: Aortic Aneurysm, Abdominal
In brief
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.
Key facts
- Study ID
- NCT01652235
- Run by
- Cook Research Incorporated
- People needed
- 28
- Starts
- 2008-07-01
- Expected to finish
- 2023-09-26
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
- Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
- Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
You may not qualify if…
- Age < 18 years
- Life expectancy < 2 years
- Pregnant or breast feeding
- Inability or refusal to give informed consent
- Unwilling or unable to comply with the follow-up schedule
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
Where it is running
- Mount Sinai-West — New York, New York, United States
- New York Presbyterian Hospital System — New York, New York, United States
Full record on ClinicalTrials.gov
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