European Aortic Data Collection Project

NCT ID: NCT05896397

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complex Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Arch Aneurysm Chronic Aortic Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular Aortic Treatments

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephan Haulon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Marie Lannelongue

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Hopital Marie Lannelongue

Le Plessis-Robinson, , France

Site Status RECRUITING

CHU de Lille

Lille, , France

Site Status RECRUITING

University Hospital Hamburg Eppendorf

Hamburg, , Germany

Site Status RECRUITING

LMU Klinikum Munich

Munich, , Germany

Site Status RECRUITING

St. Franzikus-Hospital Munster

Münster, , Germany

Site Status RECRUITING

Klinnikum Nurnberg

Nuremberg, , Germany

Site Status RECRUITING

PoliclinicoS Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

Orsola Maplighi

Bologna, , Italy

Site Status RECRUITING

Ospedal Policlinico San Martino-HSM

Genova, , Italy

Site Status RECRUITING

IRCCS San Raffaele Hospital

Milan, , Italy

Site Status RECRUITING

Skane University Hospital Malmo

Malmo, , Sweden

Site Status RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status RECRUITING

North Bristol NHS Trust

Bristol, , United Kingdom

Site Status RECRUITING

St Thomas' Hospital

London, , United Kingdom

Site Status RECRUITING

St Barthowlomew's

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark France Germany Italy Sweden United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gregoire Masliah

Role: CONTACT

+41 795 490 954

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDR-2091

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.