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PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

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: NCT02475798
Expanded Access Status : No longer available
First Posted : June 19, 2015
Last Update Posted : December 16, 2020
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 collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

Condition or disease Intervention/treatment
Aortoiliac Aneurysms Iliac Aneurysms Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Study Design
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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Interventions
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Intervention Details:
  • Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,
    Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.
    Other Name: Branch Graft
Eligibility Criteria
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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

Inclusion Criteria:

  • An aortoiliac or iliac aneurysm of appropriate size
  • Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
  • Unsuitable arterial anatomy
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): NCT02475798


Locations
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Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: W. Anthony Lee, MD Christine E. Lynn Heart and Vascular Institute
More Information
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02475798    
Other Study ID Numbers: 05-625 CA-P2
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
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