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

Terminated

• Conditions: Abdominal Aortic Aneurysm; Aorto-iliac Aneurysm

• Registration Number: NCT01424267
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
graft patency and aneurysm exclusion	during (day 1) and after implantation through 12 months

Trial Locations

Locations (15)

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

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