European Aortic Data Collection Project

Last updated: July 7, 2025
Sponsor: Cook Research Incorporated
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Chest Pain

Aneurysm

Treatment

Endovascular Aortic Treatments

Clinical Study ID

NCT05896397
MDR-2091
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients who will be treated with a Cook CMD

Exclusion

Exclusion Criteria:

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

  2. Patients or his/her legally authorized representative objects to extraction ofpatient's data from the medical record, or unwilling to sign the Informed Consent.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Endovascular Aortic Treatments
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Hopital Marie Lannelongue

    Le Plessis-Robinson, 92350
    France

    Active - Recruiting

  • CHU de Lille

    Lille, 59037
    France

    Active - Recruiting

  • University Hospital Hamburg Eppendorf

    Hamburg, 20251
    Germany

    Active - Recruiting

  • LMU Klinikum Munich

    Munich, 80337
    Germany

    Active - Recruiting

  • St. Franzikus-Hospital Munster

    Münster, 48145
    Germany

    Active - Recruiting

  • Klinnikum Nurnberg

    Nürnberg, 90471
    Germany

    Active - Recruiting

  • Orsola Maplighi

    Bologna,
    Italy

    Active - Recruiting

  • PoliclinicoS Orsola Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Ospedal Policlinico San Martino-HSM

    Genova, 16132
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Hospital

    Milan, 20132
    Italy

    Active - Recruiting

  • Skane University Hospital Malmo

    Malmö, SE-205-02
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala, 75309
    Sweden

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • North Bristol NHS Trust

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • St Barthowlomew's

    London,
    United Kingdom

    Active - Recruiting

  • St Thomas' Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

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