Zenith® Fenestrated+ Clinical Study
Primary Purpose
Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration
Eligibility Criteria
Include Criteria:
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Exclusion Criteria:
- Age < 18 years
- Life expectancy < 2 years
- Pregnant, breast-feeding, or planning to become pregnant within 60 months
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
- Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aortic abdominal aneurysm
Arm Description
Outcomes
Primary Outcome Measures
Composite measure of device technical success and procedural safety
Percent of patients with device technical success and freedom from procedural safety events in the following criteria:
Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and
Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
Percent of patients meeting the following criteria:
Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and
Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
Secondary Outcome Measures
Full Information
NCT ID
NCT04875429
First Posted
April 19, 2021
Last Updated
July 28, 2023
Sponsor
Cook Research Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT04875429
Brief Title
Zenith® Fenestrated+ Clinical Study
Official Title
Zenith® Fenestrated+ Endovascular Graft Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
April 2030 (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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
Keywords
endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aortic abdominal aneurysm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System
Intervention Description
Endovascular aneurysm repair
Primary Outcome Measure Information:
Title
Composite measure of device technical success and procedural safety
Description
Percent of patients with device technical success and freedom from procedural safety events in the following criteria:
Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and
Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Time Frame
30 days post procedure
Title
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
Description
Percent of patients meeting the following criteria:
Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and
Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
Time Frame
12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Include Criteria:
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Exclusion Criteria:
Age < 18 years
Life expectancy < 2 years
Pregnant, breast-feeding, or planning to become pregnant within 60 months
Inability or refusal to give informed consent by the patient or legally authorized representative
Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chanda Bell, RN, BSN
Phone
765-463-7537
Ext
321506
Email
chanda.bell@cookmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pooja Aboti
Phone
+45 56868749
Email
pooja.a@cookmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Oderich, MD
Organizational Affiliation
Memorial Hermann Texas Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Learn more about this trial
Zenith® Fenestrated+ Clinical Study
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