Zenith® p-Branch® OTS Multicenter Study
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: p-Branch®
- Registration Number
- NCT01740700
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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 p-Branch® p-Branch® -
- Primary Outcome Measures
Name Time Method Technical success Within 30 days Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
Community Heart and Vascular Hospital
🇺🇸Indianapolis, Indiana, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States