Zenith® p-Branch® Endovascular Graft Pivotal Study

Aortic Aneurysm Abdominal Clinical Trial

Official title:

Zenith® p-Branch® Pivotal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02396199
• Other study ID #: 14-09
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2025
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm Abdominal
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama Birmingham Hosptial	Birmingham	Alabama
United States	Boca Raton Community Hospita	Boca Raton	Florida
United States	UT Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	The Methodist Hospital - Smith Tower	Houston	Texas
United States	Methodist Hospital of Indiana	Indianapolis	Indiana
United States	Baylor Scott and White Research Institute	Irving	Texas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Inst. Foundation	Minneapolis	Minnesota
United States	Mount Sinai Roosevelt	New York	New York
United States	New York University - Langone Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center-Dignity Health	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Barnes Jewish Hospital Plaza	Saint Louis	Missouri
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	Kaiser Permanente	San Francisco	California
United States	Stanford University Medical School	Stanford	California
United States	Tampa General Hospital	Tampa	Florida
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success Proportion	Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications	12 months