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

This study has been completed.
Information provided by (Responsible Party):
Cook Group Incorporated Identifier:
First received: March 21, 2011
Last updated: March 11, 2013
Last verified: March 2013
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: 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
Endovascular Repair
Device: ZLP
ZLP Graft


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01326884

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

Responsible Party: Cook Group Incorporated Identifier: NCT01326884     History of Changes
Other Study ID Numbers: 10-004
Study First Received: March 21, 2011
Last Updated: March 11, 2013

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

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on August 16, 2017