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

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.
ClinicalTrials.gov Identifier: NCT01424267
Recruitment Status : Terminated (The registry was discontinued due to significant resources required.)
First Posted : August 26, 2011
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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 or disease Intervention/treatment
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Device: Zenith® Low Profile AAA Endovascular Graft

Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® LP AAA Endovascular Graft Post-Market Registry
Study Start Date : July 2010
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

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

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

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.

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

AKH (General Hospital Vienna)
Vienna, Austria
UHZ Hamburg GmbH (Eppendorf University Hospital)
Hamburg, Germany
Klinikum rechts der Isar (RDI Munich)
Munich, Germany
Klinikum Nürnberg Süd
Nürnberg, Germany
Royal Victoria Hospital
Belfast, Ireland
Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara
Modena, Italy
Azoemda ospedaliera San Camillo Forlanini
Rome, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
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

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01424267     History of Changes
Other Study ID Numbers: 10-006
First Posted: August 26, 2011    Key Record Dates
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:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases