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

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. Identifier: NCT01326884
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : March 12, 2013
Information provided by (Responsible Party):
Cook Group Incorporated

March 21, 2011
March 31, 2011
March 12, 2013
February 2011
November 2012   (Final data collection date for primary outcome measure)
Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 12 months ]
Same as current
Complete list of historical versions of study NCT01326884 on Archive Site
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Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
ZLP Clinical Study
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysm
  • Aorto-iliac Aneurysm
  • Iliac Aneurysm
Device: ZLP
ZLP Graft
Endovascular Repair
Intervention: Device: ZLP
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Cook Group Incorporated
Cook Group Incorporated
Not Provided
Principal Investigator: Ronald M. Fairman, MD University of Pennsylvania
Cook Group Incorporated
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP