Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

October 10, 2012 updated by: Cook Group Incorporated

Zenith® LP AAA Endovascular Graft Post-Market Registry

A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • AKH (General Hospital Vienna)
  • Germany
      • Hamburg, Germany
        • UHZ Hamburg GmbH (Eppendorf University Hospital)
      • Munich, Germany
        • Klinikum rechts der Isar (RDI Munich)
      • Nürnberg, Germany
        • Klinikum Nürnberg Süd
  • Ireland
      • Belfast, Ireland
        • Royal Victoria Hospital
  • Italy
      • Modena, Italy
        • Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara
      • Rome, Italy
        • Azoemda ospedaliera San Camillo Forlanini
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Maastricht, Netherlands
        • Maastricht University Medical Center
  • Norway
      • Trondheim, Norway
        • St. Olav University Hospital
  • United Kingdom
      • London, United Kingdom
        • St. Mary's Hospital
      • London, United Kingdom
        • Guy's and St. Thomas' Hospital
      • Manchester, United Kingdom
        • Manchester Royal Informary
      • Newcastle Upon Tyne, United Kingdom
        • Freeman Hospital
      • Wales, United Kingdom
        • Royal Gwent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft

Description

Inclusion Criteria:

  • Patient is implanted with Zenith® Low Profile AAA Endovascular Graft

Exclusion Criteria:

  • Patients for whom this device would not normally be considered standard of care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Device: Zenith® Low Profile AAA Endovascular Graft
Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
graft patency and aneurysm exclusion
Time Frame: during (day 1) and after implantation through 12 months
during (day 1) and after implantation through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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