Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study (FENP)
Primary Purpose
Aortic Aneurysm, Abdominal
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
Eligibility Criteria
Inclusion Criteria:
- Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
- Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
- Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
Exclusion Criteria:
- Age < 18 years
- Life expectancy < 2 years
- Pregnant or breast feeding
- Inability or refusal to give informed consent
- Unwilling or unable to comply with the follow-up schedule
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan
Sites / Locations
- Mount Sinai-West
- New York Presbyterian Hospital System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endovascular
Arm Description
Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Outcomes
Primary Outcome Measures
evaluate perfusion of visceral vessels
evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)
Secondary Outcome Measures
Full Information
NCT ID
NCT01652235
First Posted
July 17, 2012
Last Updated
December 7, 2022
Sponsor
Cook Research Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01652235
Brief Title
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Acronym
FENP
Official Title
Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft 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, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endovascular
Arm Type
Experimental
Arm Description
Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Intervention Type
Device
Intervention Name(s)
Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Other Intervention Name(s)
Endovascular stent, Stent-graft
Intervention Description
Instead of making a large incision in the chest, 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
evaluate perfusion of visceral vessels
Description
evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
Exclusion Criteria:
Age < 18 years
Life expectancy < 2 years
Pregnant or breast feeding
Inability or refusal to give informed consent
Unwilling or unable to comply with the follow-up schedule
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
James F. McKinsey, MD
Organizational Affiliation
Mount Sinai-West
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai-West
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
New York Presbyterian Hospital System
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study
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