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PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571907
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Description
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Brief Summary:
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.

Condition or disease Intervention/treatment Phase
Aortoiliac Aneurysms Iliac Aneurysms Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation, Device: Atrium iCAST™ Device: Zenith® Flex AAA Endovascular Graft Not Applicable

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
 Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Other Name: Branch Graft

Device: Atrium iCAST™
Implantation of Atrium iCAST

Device: Zenith® Flex AAA Endovascular Graft
Implantation of the Zenith Flex Endovascular Graft


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Freedom from morbidity (i.e., morbidity index) [ Time Frame: 30 days ]
    Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).


Eligibility Criteria
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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

Inclusion Criteria:

  • An aortioiliac or iliac aneurysm
  • An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
  • Unwilling or unable to comply with the follow-up schedule
  • Simultaneously participating in another investigative device or drug study
Contacts and Locations
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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): NCT02571907


Locations
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Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: W. Anthony Lee, MD FACS Christine E. Lynn Heart and Vascular Institute
More Information
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02571907    
Other Study ID Numbers: 05-625 P2
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Zenith aortoiliac aneurysm
Iliac aneurysm
Branch
Connections
Endovascular graft
 Graft-iliac bifurcation
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases