NCT05896397 European Aortic Data Collection Project
| NCT ID | NCT05896397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cook Research Incorporated |
| Condition | Complex Abdominal Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-05-31 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Stephan Haulon, MD,PhD
PRINCIPAL INVESTIGATOR
Hopital Marie Lannelongue
Frequently Asked Questions
Who can join the NCT05896397 clinical trial?
This trial is open to participants of all sexes, studying Complex Abdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896397 currently recruiting?
Yes, NCT05896397 is actively recruiting participants. Contact the research team at gregoire.masliah@cookmedical.com for enrollment information.
Where is the NCT05896397 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Le Plessis-Robinson, France, Lille, France and 11 additional locations.
Who is sponsoring the NCT05896397 clinical trial?
NCT05896397 is sponsored by Cook Research Incorporated. The principal investigator is Stephan Haulon, MD,PhD at Hopital Marie Lannelongue. The trial plans to enroll 600 participants.