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

This study has been terminated.
(The registry was discontinued due to significant resources required.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424267
First Posted: August 26, 2011
Last Update Posted: October 11, 2012
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
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.

Condition Intervention
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Device: Zenith® Low Profile AAA Endovascular Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® LP AAA Endovascular Graft Post-Market Registry

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • graft patency and aneurysm exclusion [ Time Frame: during (day 1) and after implantation through 12 months ]

Enrollment: 76
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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 a CE-Marked Zenith® Low Profile AAA Endovascular Graft
Criteria

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.
  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): NCT01424267


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

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01424267     History of Changes
Other Study ID Numbers: 10-006
First Submitted: August 23, 2011
First Posted: August 26, 2011
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Cook Group Incorporated:
low profile
endovascular graft
endovascular procedure
aortic aneurysm, abdominal aortic aneurysm

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