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NCT01424267 Clinical Trial

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

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Zenith® LP AAA Endovascular Graft Post-Market Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01424267
Other study ID # 10-006
Secondary ID
Status Terminated
Phase N/A
First received August 23, 2011
Last updated October 10, 2012
Start date July 2010
Est. completion date August 2012

Study information
Verified date October 2012
Source Cook
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 76
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

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

Sponsors (1)
Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

Austria,  Germany,  Ireland,  Italy,  Netherlands,  Norway,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary graft patency and aneurysm exclusion during (day 1) and after implantation through 12 months No
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