Zenith® p-Branch™: Single-Center Study
This trial is active, not recruiting.
|Conditions||aortic aneurysm, abdominal aortic aneurysm|
|Treatment||endovascular treatment (zenith® p-branch™ endovascular graft)|
|Start date||June 2012|
|End date||October 2015|
|Trial size||23 participants|
|Trial identifier||NCT01663064, 11-018|
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.
|Intervention model||single group assignment|
time frame: Up to 5 years
Male or female participants at least 18 years old.
- Pararenal or juxtarenal AAA >5.0 cm in diameter
- Pararenal or juxtarenal AAA with history of growth >0.5 cm/year
- Age < 18 years
- Life expectancy < 2 years
- Pregnant or breast feeding
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- 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
|Official title||Zenith® p-Branch™: Single-Center Study|
|Principal investigator||Timothy A. Resch, MD, PhD|
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