Clinical trial NCT02396199: Zenith® p-Branch® Endovascular Graft Pivotal Study
Official title: Zenith® p-Branch® Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm Abdominal
Keywords: Abdominal aortic aneurysm
Endovascular
Juxtarenal
Pararenal
Fenestrated
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Success Proportion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hosptial
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center-Dignity Health
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Stanford
country: United States
facility: Stanford University Medical School
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Community Hospita
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Inst. Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital Plaza
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: New York
country: United States
facility: New York University - Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Roosevelt
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital - Smith Tower
state: Texas
city: Irving
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: University of North Carolina
name: Mark A Farber, MD
role: PRINCIPAL_INVESTIGATOR
References: