European Aortic Data Collection Project

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.

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Key information

Conditions

Complex Abdominal Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Thoracoabdominal Aortic Arch Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Chronic Aortic Dissection Dissection, Blood Vessel Thoracoabdominal Aortic Aneurysm Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who will be treated with a Cook CMD

Exclusion criteria

Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
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.

Treatment and study plan

Endovascular Aortic Treatments

Procedure

Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.

Primary outcomes

Rate of treatment success

Time frame: 12 months

Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components.
Rate of safety outcomes

Time frame: 30 days

Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy)

Study contacts

Contact information is provided by the study sponsor or research team.

Gregoire Masliah

CONTACT

[email protected]

+41 795 490 954

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Acronym: EADC

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2030
First posted: Jun 9, 2023
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting