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The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Hopital Marie Lannelongue
Le Plessis-Robinson, France
CHU de Lille
Lille, France
University Hospital Hamburg Eppendorf
Hamburg, Germany
LMU Klinikum Munich
Munich, Germany
St. Franzikus-Hospital Munster
Münster, Germany
Klinnikum Nurnberg
Nuremberg, Germany
PoliclinicoS Orsola Malpighi
Bologna, Italy
Orsola Maplighi
Bologna, Italy
Start Date
May 31, 2023
Primary Completion Date
January 1, 2027
Completion Date
December 1, 2030
Last Updated
July 8, 2025
600
ESTIMATED participants
Endovascular Aortic Treatments
PROCEDURE
Lead Sponsor
Cook Research Incorporated
NCT02089607
NCT06710938
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01874197