We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540643
First Posted: February 29, 2012
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 23, 2012
First Posted: February 29, 2012
Last Update Posted: January 20, 2017
Last Verified: January 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