Thoracoabdominal Aortic Aneurysm Clinical Trial
— EADCOfficial title:
European Aortic Data Collection Project
NCT number | NCT05896397 |
Other study ID # | MDR-2091 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2023 |
Est. completion date | December 2030 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2030 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Rigshospitalet | Copenhagen | |
France | Hopital Marie Lannelongue | Le Plessis-Robinson | |
France | CHU de Lille | Lille | |
Germany | University Hospital Hamburg Eppendorf | Hamburg | |
Germany | LMU Klinikum Munich | Munich | |
Germany | St. Franzikus-Hospital Munster | Münster | |
Germany | Klinnikum Nurnberg | Nürnberg | |
Italy | PoliclinicoS Orsola Malpighi | Bologna | |
Italy | Ospedal Policlinico San Martino-HSM | Genova | |
Italy | IRCCS San Raffaele Hospital | Milan | |
Sweden | Skane University Hospital Malmo | Malmö | |
Sweden | Uppsala University Hospital | Uppsala | |
United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
United Kingdom | North Bristol NHS Trust | Bristol | |
United Kingdom | St Thomas' Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Cook Research Incorporated |
Denmark, France, Germany, Italy, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of treatment success | Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components. | 12 months | |
Primary | Rate of safety outcomes | Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy) | 30 days |
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