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

Terminated

• Conditions: Abdominal Aortic Aneurysm; Aorto-iliac Aneurysm
• Interventions: Device: Zenith® Low Profile AAA Endovascular Graft

• 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

Arm && Interventions

Group	Intervention	Description
1	Zenith® Low Profile AAA Endovascular Graft	-

Primary Outcome Measures

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

Trial Locations

Locations (15)

Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara; 🇮🇹 Modena, Italy

Klinikum Nürnberg Süd; 🇩🇪 Nürnberg, Germany

Manchester Royal Informary; 🇬🇧 Manchester, United Kingdom

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Guy's and St. Thomas' Hospital; 🇬🇧 London, United Kingdom

Royal Gwent Hospital; 🇬🇧 Wales, United Kingdom

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

AKH (General Hospital Vienna); 🇦🇹 Vienna, Austria

Klinikum rechts der Isar (RDI Munich); 🇩🇪 Munich, Germany

Azoemda ospedaliera San Camillo Forlanini; 🇮🇹 Rome, Italy

UHZ Hamburg GmbH (Eppendorf University Hospital); 🇩🇪 Hamburg, Germany

Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Royal Victoria Hospital; 🇮🇪 Belfast, Ireland

St. Olav University Hospital; 🇳🇴 Trondheim, Norway