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Recruiting
NCT05896397
European Aortic Data Collection Project
Conditions: Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
Sex: All
Healthy volunteers: No
Enrollment: 600
Sponsor: Cook Research Incorporated
Location: Aarhus University Hospital Aarhus Denmark
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1\. Patients who will be treated with a Cook CMD
Exclusion Criteria:
1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
2. Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.
Source: ClinicalTrials.gov (NCT05896397). StuddyBuddy aggregates publicly available trial information.
