Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01540643
First received: February 23, 2012
Last updated: November 1, 2016
Last verified: October 2016

February 23, 2012
November 1, 2016
March 2012
March 2016   (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
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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.
 
Active, not recruiting
600
December 2016
March 2016   (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
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01540643
11-015
Not Provided
Not Provided
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Thomas Lindsay Toronto General Hospital
Cook
October 2016

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