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Zenith® p-Branch® Endovascular Graft Pivotal Study

Primary Purpose

Aortic Aneurysm Abdominal

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm Abdominal focused on measuring Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham Hosptial
  • St. Joseph's Hospital and Medical Center-Dignity Health
  • Ronald Reagan UCLA Medical Center
  • Kaiser Permanente
  • Stanford University Medical School
  • Hartford Hospital
  • Boca Raton Community Hospita
  • Tampa General Hospital
  • Emory University Hospital
  • Methodist Hospital of Indiana
  • Johns Hopkins Hospital
  • University of Massachusetts Medical School
  • Minneapolis Heart Inst. Foundation
  • Mayo Clinic Rochester
  • Barnes Jewish Hospital Plaza
  • Mercy Hospital St. Louis
  • New York University - Langone Medical Center
  • Mount Sinai Roosevelt
  • Duke University Medical Center
  • Oregon Health and Science University
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • UT Southwestern
  • Michael E. DeBakey VA Medical Center
  • The Methodist Hospital - Smith Tower
  • Baylor Scott and White Research Institute
  • Aurora Saint Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular

Arm Description

Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 12, 2015
Last Updated
December 7, 2022
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02396199
Brief Title
Zenith® p-Branch® Endovascular Graft Pivotal Study
Official Title
Zenith® p-Branch® Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm Abdominal
Keywords
Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular
Arm Type
Experimental
Arm Description
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Intervention Type
Device
Intervention Name(s)
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Other Intervention Name(s)
Endovascular graft, Endovascular stent, Stent-graft, Fenestrated graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Success Proportion
Description
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Farber, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham Hosptial
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center-Dignity Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford University Medical School
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-8000
Country
United States
Facility Name
Boca Raton Community Hospita
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Methodist Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Minneapolis Heart Inst. Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes Jewish Hospital Plaza
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New York University - Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital - Smith Tower
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott and White Research Institute
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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Zenith® p-Branch® Endovascular Graft Pivotal Study

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