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Zenith® Fenestrated+ Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04875429
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

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) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Extent IV Thoracoabdominal Pararenal Aneurysm Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® Fenestrated+ Endovascular Graft Clinical Study
Actual Study Start Date : December 8, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Aortic abdominal aneurysm Device: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Endovascular aneurysm repair




Primary Outcome Measures :
  1. Composite measure of device technical success and procedural safety [ Time Frame: 30 days post procedure ]

    Percent of patients with device technical success and freedom from procedural safety events in the following criteria:

    1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and
    2. 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

  2. Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention [ Time Frame: 12 months post procedure ]

    Percent of patients meeting the following criteria:

    1. 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
    2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Include Criteria:

  1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875429


Contacts
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Contact: Chanda Bell, RN, BSN 765-463-7537 ext 321506 chanda.bell@cookmedical.com
Contact: Pooja Aboti +45 56868749 pooja.a@cookmedical.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Gustavo Oderich, MD Memorial Hermann Texas Medical Center
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT04875429    
Other Study ID Numbers: 17-07
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
endovascular
Vascular Diseases
Cardiovascular Diseases
Fenestration
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases