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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 18 sites (Aarhus, Denmark and 17 other locations) |
| Status | Recruiting |
| Started | May 31, 2023 |
| Main results expected | January 2027 |
| Study ends | December 2030 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT05896397 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
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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
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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
- Principal investigator: Stephan Haulon, MD,PhD — Hopital Marie Lannelongue
- Study coordinator: Gregoire Masliah
- Email: gregoire.masliah@cookmedical.com
- Phone: +41 795 490 954
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Repairing complex aortic aneurysms with a specialized stent-graft
This study is testing a special stent-graft to see if it safely and effectively repairs complex aortic aneurysms in patients who have them.
-
Arcevo LSA stent graft for repairing aortic arch dissections and aneurysms
This trial will test whether the Arcevo LSA stent graft can safely and effectively repair aortic arch and descending thoracic aortic dissections or aneurysms in adults.
-
Modified endograft treatment for complex aortic aneurysms
This study is testing a special type of stent to see if it can safely treat complex aortic aneurysms in high-risk patients who can’t use regular devices.
-
Evaluating new endografts for treating complex aortic conditions
This study is testing new types of stents for people with complicated aortic conditions to see if they are safe and effective compared to standard treatments.
-
Evaluating new endografts for treating aortic aneurysms
This study is testing two new types of stent-grafts to see if they can safely and effectively treat aortic aneurysms in patients who can't use standard treatments.
-
Femorofemoral versus left‑heart bypass for open thoracoabdominal aortic aneurysm repair
This will test whether femorofemoral bypass or left‑heart bypass works better for adults having open repair of a thoracoabdominal aortic aneurysm.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.