Clinical trial Recruiting at 18 sites Observational

Collecting data on custom-made stent-graft devices for aortic treatment

Official title: European Aortic Data Collection Project

Run by Cook Group Incorporated · NCT05896397 · Data updated 2026-11-12

This study is testing how safe and effective custom-made stent-grafts are for treating complex aortic conditions in real-world settings.

Quick facts

Study typeObservational
SexAll
Enrollment600 (estimated)
SponsorCook Group Incorporated
Industry-sponsored
Locations18 sites (Aarhus, Denmark and 17 other locations)
StatusRecruiting
StartedMay 31, 2023
Main results expectedJanuary 2027
Study endsDecember 2030
Registry record updatedJune 4, 2026
Trial IDNCT05896397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients who are scheduled to receive treatment with a Cook Custom-Made Stent-graft Device.

Probably not a fit

Patients who are unable to complete clinical follow-up visits or who do not consent to data extraction will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and performance of Cook's Custom-Made Stent-graft Devices (CMD) used in the endovascular treatment of complex aortic conditions. By gathering real-world data on the use of these devices, the study seeks to support ongoing market presence and compliance with post-market surveillance requirements. The information collected will also contribute to the development of future technologies in aortic repair.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of endovascular treatments for patients with complex aortic conditions.

How similar studies have gone: Other studies evaluating similar endovascular approaches have shown promising results, indicating a potential for success in this area.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Aarhus University Hospital
    Aarhus, Denmark, Denmark
    Recruiting
  • Rigshospitalet
    Copenhagen, Denmark, Denmark
    Recruiting
  • Hopital Marie Lannelongue
    Le Plessis-Robinson, France
    Recruiting
  • CHU de Lille
    Lille, France
    Recruiting
  • University Hospital Hamburg Eppendorf
    Hamburg, Germany, Germany
    Recruiting
  • LMU Klinikum Munich
    Munich, Germany, Germany
    Recruiting
Show 12 more locations
  • St. Franzikus-Hospital Munster
    Münster, Germany, Germany
    Recruiting
  • Klinnikum Nurnberg
    Nuremberg, Germany, Germany
    Recruiting
  • PoliclinicoS Orsola Malpighi
    Bologna, Italy
    Recruiting
  • Orsola Maplighi
    Bologna, Italy
    Recruiting
  • Ospedal Policlinico San Martino-HSM
    Genova, Italy
    Recruiting
  • IRCCS San Raffaele Hospital
    Milan, Italy
    Recruiting
  • Skane University Hospital Malmo
    Malmö, Sweden
    Recruiting
  • Uppsala University Hospital
    Uppsala, Sweden
    Recruiting
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
    Recruiting
  • North Bristol NHS Trust
    Bristol, United Kingdom
    Recruiting
  • St Thomas' Hospital
    London, United Kingdom
    Recruiting
  • St Barthowlomew's
    London, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.