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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:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01424267
First received: August 23, 2011
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • graft patency and aneurysm exclusion [ Time Frame: during (day 1) and after implantation through 12 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
St. Mary's Hospital
London, United Kingdom
Guy's and St. Thomas' 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
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01424267     History of Changes
Other Study ID Numbers: 10-006
Study First Received: August 23, 2011
Last Updated: October 10, 2012
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on June 18, 2013