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Summary
Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It is designed to evaluate safety and performance of the MFM for the treatment of chronic type B aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed patients. For early demonstration of safety and performance, an interim analysis report will be performed after all patients included will complete their 6-month follow-up. The study purpose is to determine the safety and performance of the MFM for the endovascular treatment of chronic type B aortic dissection. It should be noted that the MFM has CE mark approval for aortic and peripheral artery aneurysms treatment.
Official title: Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2016-01
Completion Date
2029-12
Last Updated
2024-02-07
Healthy Volunteers
No
Conditions
Interventions
Implantation with the Multilayer Flow Modulator (MFM)
Endovascular implantation with the MFM
Locations (4)
City Clinic Burgas
Burgas, Bulgaria
City Clinic Sofia
Sofia, Bulgaria
Sanador Hospital
Bucharest, Romania
European Hospital Polisano
Sibiu, Romania