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Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study (ZLP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326884
First Posted: March 31, 2011
Last Update Posted: March 12, 2013
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.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

Condition Intervention
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Iliac Aneurysm Device: ZLP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZLP Clinical Study

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 12 months ]

Enrollment: 27
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Endovascular Repair
Device: ZLP
ZLP Graft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

  • Less than 20 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
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): NCT01326884


Locations
Japan
Nara Medical University
Nara, Japan, 634-8522
Jikei University Hospital
Tokyo, Japan, 105-8461
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Ronald M. Fairman, MD University of Pennsylvania
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01326884     History of Changes
Other Study ID Numbers: 10-004
First Submitted: March 21, 2011
First Posted: March 31, 2011
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Cook Group Incorporated:
aortic aneurysm
iliac aneurysm
endovascular procedures

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases