Zenith® p-Branch® Endovascular Graft Pivotal Study

Not Applicable

Completed

• Conditions: Aortic Aneurysm Abdominal

• 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

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Study Start: 2015-08
• Primary Completion: 2021-04-01
• Results First Submitted: 2022-08-09
• Results First Submitted QC: 2022-10-03
• Results First Posted: 2022-10-25
• Study Completion: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

Trial Locations

Locations (27)

University of Alabama Birmingham Hosptial; 🇺🇸 Birmingham, Alabama, United States

St. Joseph's Hospital and Medical Center-Dignity Health; 🇺🇸 Phoenix, Arizona, 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

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Boca Raton Community Hospita; 🇺🇸 Boca Raton, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Methodist Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States

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