Zenith® p-Branch® Endovascular Graft Pivotal Study
- Conditions
- Aortic Aneurysm Abdominal
- Interventions
- Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
- Registration Number
- NCT02396199
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
- Primary Outcome Measures
Name Time Method Treatment Success Proportion 12 months Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
Minneapolis Heart Inst. Foundation
🇺🇸Minneapolis, Minnesota, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Boca Raton Community Hospita
🇺🇸Boca Raton, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital and Medical Center-Dignity Health
🇺🇸Phoenix, Arizona, United States
Mount Sinai Roosevelt
🇺🇸New York, New York, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Baylor Scott and White Research Institute
🇺🇸Irving, Texas, United States
New York University - Langone Medical Center
🇺🇸New York, New York, United States
The Methodist Hospital - Smith Tower
🇺🇸Houston, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Alabama Birmingham Hosptial
🇺🇸Birmingham, Alabama, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
Stanford University Medical School
🇺🇸Stanford, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Barnes Jewish Hospital Plaza
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States