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

NCT ID: NCT01424267

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm Aorto-iliac Aneurysm

Keywords

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low profile endovascular graft endovascular procedure aortic aneurysm, abdominal aortic aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Zenith® Low Profile AAA Endovascular Graft

Intervention Type DEVICE

Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AKH (General Hospital Vienna)

Vienna, , Austria

Site Status

UHZ Hamburg GmbH (Eppendorf University Hospital)

Hamburg, , Germany

Site Status

Klinikum rechts der Isar (RDI Munich)

Munich, , Germany

Site Status

Klinikum Nürnberg Süd

Nuremberg, , Germany

Site Status

Royal Victoria Hospital

Belfast, , Ireland

Site Status

Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara

Modena, , Italy

Site Status

Azoemda ospedaliera San Camillo Forlanini

Rome, , Italy

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

St. Olav University Hospital

Trondheim, , Norway

Site Status

Guy's and St. Thomas' Hospital

London, , United Kingdom

Site Status

St. Mary's Hospital

London, , United Kingdom

Site Status

Manchester Royal Informary

Manchester, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Royal Gwent Hospital

Wales, , United Kingdom

Site Status

Countries

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Austria Germany Ireland Italy Netherlands Norway United Kingdom

Other Identifiers

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10-006

Identifier Type: -

Identifier Source: org_study_id