European Aortic Data Collection Project (EADC)

Cook Group

Status: Enrolling

Conditions: Chronic Aortic Dissection; Complex Abdominal Aortic Aneurysm; Aortic Arch Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Procedure: Endovascular Aortic Treatments

Study type: Observational

Funder types: Industry

Identifiers

NCT05896397

MDR-2091

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.