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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
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 endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration

Eligibility Criteria

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

Include Criteria:

  1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
  2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
  3. 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:

  1. Age < 18 years
  2. Life expectancy < 2 years
  3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
  4. Inability or refusal to give informed consent by the patient or legally authorized representative
  5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
  6. 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

    First Posted
    April 19, 2021
    Last Updated
    July 28, 2023
    Sponsor
    Cook Research Incorporated
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    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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