Actively Recruiting

All Genders
ID05896397

European Aortic Data Collection Project

Led by Cook Research Incorporated · Updated on 2026-06-04

600

Participants Needed

18

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess the safety and performance of Cook's various custom-made stent-graft devices used for endovascular treatment of complex abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, aortic arch aneurysms, and chronic aortic dissections. The study collects real-world data on the use of these devices to support their ongoing market availability and post-market surveillance as well as further technological development by Cook. Participants will receive treatment using Cook's custom-made endovascular grafts designed for complex aortic diseases. The study is observational and does not involve assigning participants to specific treatment groups but rather monitors patients receiving these devices in usual care settings. During the study, researchers will track treatment success rates at 12 months and safety outcomes within 30 days after treatment. Participants will undergo clinical follow-up visits to monitor outcomes. The study results will contribute to understanding device performance and safety in real-world use. The study will continue until December 2030.

CONDITIONS

Brief Title

European Aortic Data Collection Project

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who will be treated with a Cook custom-made stent-graft device
Not Eligible

You will not qualify if you...

  • Patients unable to complete clinical follow-up visits at enrollment
  • Patients or their legal representatives who refuse consent for medical record data extraction or to sign informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Varies depending on individual treatment

Participants undergo endovascular aortic treatments using Cook's custom-made endovascular grafts for complex aortic diseases.

Long-term Monitoring

Duration - Up to 12 months

Participants are observed following treatment to assess treatment success and safety outcomes over time.

Follow-up visits including clinical assessments up to 12 months after treatment

Trial Site Locations

Total: 18 locations

1

Aarhus University Hospital

Aarhus, Denmark, Denmark, 8200

Actively Recruiting

2

Rigshospitalet

Copenhagen, Denmark, Denmark, 2100

Actively Recruiting

3

Hopital Marie Lannelongue

Le Plessis-Robinson, France, 92350

Actively Recruiting

4

CHU de Lille

Lille, France, 59037

Actively Recruiting

5

University Hospital Hamburg Eppendorf

Hamburg, Germany, Germany, 20251

Actively Recruiting

6

LMU Klinikum Munich

Munich, Germany, Germany, 80337

Actively Recruiting

7

St. Franzikus-Hospital Munster

Münster, Germany, Germany, 48145

Actively Recruiting

8

Klinnikum Nurnberg

Nuremberg, Germany, Germany, 90471

Actively Recruiting

9

PoliclinicoS Orsola Malpighi

Bologna, Italy, 40138

Actively Recruiting

10

Orsola Maplighi

Bologna, Italy

Actively Recruiting

11

Ospedal Policlinico San Martino-HSM

Genova, Italy, 16132

Actively Recruiting

12

IRCCS San Raffaele Hospital

Milan, Italy, 20132

Actively Recruiting

13

Skane University Hospital Malmo

Malmö, Sweden, SE-205-02

Actively Recruiting

14

Uppsala University Hospital

Uppsala, Sweden, 75309

Actively Recruiting

15

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B9 5SS

Actively Recruiting

16

North Bristol NHS Trust

Bristol, United Kingdom, BS10 5NB

Actively Recruiting

17

St Thomas' Hospital

London, United Kingdom, SE1 9RT

Actively Recruiting

18

St Barthowlomew's

London, United Kingdom

Actively Recruiting

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Research Team

G

Gregoire Masliah

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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