ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Iliac Aneurysm Device: ZLP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZLP Clinical Study
Study Start Date : February 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1
Endovascular Repair
Device: ZLP
ZLP Graft



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01326884     History of Changes
Other Study ID Numbers: 10-004
First Posted: March 31, 2011    Key Record Dates
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