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
  Purpose

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


Condition Intervention
Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Device: Iliac Leg Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Abdominal aortic aneurysm Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540643

  Show 21 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Thomas Lindsay Toronto General Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01540643     History of Changes
Other Study ID Numbers: 11-015
Study First Received: February 23, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cook:
abdominal aortic aneurysm
iliac leg graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 22, 2014