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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 29, 2014