Zenith® p-Branch® Endovascular Graft Pivotal Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2019 |
| Start Date: | August 2015 |
| End Date: | November 2025 |
| Contact: | Morgan Griffith |
| Email: | morgan.griffith@cookmedical.com |
| Phone: | 800-468-1379 |
Zenith® p-Branch® Pivotal Study
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety
and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium
iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium
iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Inclusion Criteria:
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria:
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- 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
- Simultaneously participating in another investigative device or drug study. (The
patient must have completed the primary endpoint of any previous study at least 30
days prior to enrollment in this study.)
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
We found this trial at
32
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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