Collecting data on custom-made stent-graft devices for aortic treatment
European Aortic Data Collection Project
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 18 sites (Aarhus and 17 other locations) |
| Trial ID | NCT05896397 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are scheduled to receive treatment with a Cook Custom-Made Stent-graft Device.
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.
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 performed: Other studies evaluating similar endovascular approaches have shown promising results, indicating a potential for success in this area.
Eligibility criteria
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 this trial is running
Aarhus and 17 other locations
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Hopital Marie Lannelongue — Le Plessis-Robinson, France (Recruiting)
- CHU de Lille — Lille, France (Recruiting)
- University Hospital Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- LMU Klinikum Munich — Munich, Germany (Recruiting)
- St. Franzikus-Hospital Munster — Münster, Germany (Recruiting)
- Klinnikum Nurnberg — Nuremberg, 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: gregoie.masliah@cookmedical.com
- Phone: +41 795 490 954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.