This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT01540643
First received: February 23, 2012
Last updated: January 19, 2017
Last verified: January 2017
  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 Group Incorporated:

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 ]

Enrollment: 600
Study Start Date: March 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 31 Study Locations
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Thomas Lindsay Toronto General Hospital
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01540643     History of Changes
Other Study ID Numbers: 11-015
Study First Received: February 23, 2012
Last Updated: January 19, 2017

Keywords provided by Cook Group Incorporated:
abdominal aortic aneurysm
iliac leg graft

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

ClinicalTrials.gov processed this record on September 21, 2017