Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01540643
First received: February 23, 2012
Last updated: February 6, 2014
Last verified: February 2014

February 23, 2012
February 6, 2014
March 2012
February 2015   (final data collection date for primary outcome measure)
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540643 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft

  • Abdominal Aortic Aneurysm
  • Aorto-iliac Aneurysm
Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft
Abdominal aortic aneurysm
Intervention: Device: Iliac Leg Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 2016
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.

Exclusion Criteria:

  • Patients for whom this device would not normally be considered standard of care.
Both
Not Provided
No
Not Provided
United States,   Canada
 
NCT01540643
11-015
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Thomas Lindsay Toronto General Hospital
Cook
February 2014

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