Zenith® p-Branch® Endovascular Graft Pivotal Study
Key facts
- Where
- Atlanta, Baltimore, Birmingham, Boca Raton, Dallas, Durham, Hartford, Houston, Indianapolis, Irving, Los Angeles, Milwaukee, Minneapolis, New York, Philadelphia, Phoenix, Pittsburgh, Portland, Rochester, San Francisco, St Louis, Stanford, Tampa, and Worcester, United StatesSee the 27 sites
Where in United States
- Emory University HospitalAtlanta, United StatesNo longer taking part
- Johns Hopkins HospitalBaltimore, United StatesNo longer taking part
- University of Alabama Birmingham HosptialBirmingham, United StatesNo longer taking part
- Boca Raton Community HospitaBoca Raton, United StatesNo longer taking part
- UT SouthwesternDallas, United StatesNo longer taking part
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Hartford HospitalHartford, United StatesNo longer taking part
- Michael E. DeBakey VA Medical CenterHouston, United StatesNo longer taking part
- The Methodist Hospital - Smith TowerHouston, United StatesNo longer taking part
- Methodist Hospital of IndianaIndianapolis, United StatesNo longer taking part
- Baylor Scott and White Research InstituteIrving, United StatesNo longer taking part
- Ronald Reagan UCLA Medical CenterLos Angeles, United StatesNo longer taking part
- Aurora Saint Luke's Medical CenterMilwaukee, United StatesNo longer taking part
- Minneapolis Heart Inst. FoundationMinneapolis, United StatesNo longer taking part
- Mount Sinai RooseveltNew York, United StatesNo longer taking part
- New York University Langone Medical CenterNew York, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- St. Joseph's Hospital and Medical Center-Dignity HealthPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- Kaiser PermanenteSan Francisco, United StatesNo longer taking part
- Barnes Jewish Hospital PlazaSt Louis, United StatesNo longer taking part
- Mercy Hospital St. LouisSt Louis, United StatesNo longer taking part
- Stanford University Medical SchoolStanford, United StatesNo longer taking part
- Tampa General HospitalTampa, United StatesNo longer taking part
- University of Massachusetts Medical SchoolWorcester, United StatesNo longer taking part
Trial details
- Who runs it
- Cook Research Incorporated
- Trial code
- NCT02396199
- Record updated
- 19 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.); 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; Additional medical restrictions as specified in the Clinical Investigation Plan; Additional anatomical restrictions as specified in the Clinical Investigation Plan.