Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients who will be treated with a Cook custom-made stent-graft device
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies depending on individual treatment
Participants undergo endovascular aortic treatments using Cook's custom-made endovascular grafts for complex aortic diseases.
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
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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