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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach

7 countries

15 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

July 1, 2010

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed

Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

2.1 years

First QC Date

August 23, 2011

Last Update Submit

October 10, 2012

Conditions

Abdominal Aortic Aneurysm Aorto-iliac Aneurysm

Keywords

low profileendovascular graftendovascular procedureaortic aneurysm, abdominal aortic aneurysm

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

1

Device: Zenith® Low Profile AAA Endovascular Graft

Interventions

Zenith® Low Profile AAA Endovascular GraftDEVICE

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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft

You may qualify if:

Patient is implanted with Zenith® Low Profile AAA Endovascular Graft

You may not qualify if:

Patients for whom this device would not normally be considered standard of care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cook Group Incorporatedlead

Study Sites (15)

AKH (General Hospital Vienna)

Vienna, Austria

Location

UHZ Hamburg GmbH (Eppendorf University Hospital)

Hamburg, Germany

Location

Klinikum rechts der Isar (RDI Munich)

Munich, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

Royal Victoria Hospital

Belfast, Ireland

Location

Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara

Modena, Italy

Location

Azoemda ospedaliera San Camillo Forlanini

Rome, Italy

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

St. Olav University Hospital

Trondheim, Norway

Location

Guy's and St. Thomas' Hospital

London, United Kingdom

Location

St. Mary's Hospital

London, United Kingdom

Location

Manchester Royal Informary

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Royal Gwent Hospital

Wales, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

July 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

NL(2)NO(1)DE(3)IE(1)AU(1)GB(5)IT(2)

Study Stopped

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (15)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations