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Dragon Study Europe

Cardiatis · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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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.
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