Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01326884
First received: March 21, 2011
Last updated: March 11, 2013
Last verified: March 2013

March 21, 2011
March 11, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01326884 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysm
  • Aorto-iliac Aneurysm
  • Iliac Aneurysm
Device: ZLP
ZLP Graft
1
Endovascular Repair
Intervention: Device: ZLP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01326884
10-004
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Ronald M. Fairman, MD University of Pennsylvania
Cook
March 2013

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