Coronary Artery Disease Clinical Trial
Official title:
BIOTRONIK-Safety and Clinical Performance of the Drug Eluting Resorbable Coronary MAGnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial
The objective of this study is to assess the safety and efficacy of the DREAMS 3G in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
The Biotronik BIOMAG-II clinical trial is a prospective, international, multi-center, randomized controlled, non-inferiority trial to compare the BIOTRONIK Sirolimus Eluting Resorbable Magnesium Scaffold System (DREAMS 3G RMS) with the Xience Everolimus Eluting Stent System (Xience DES) with respect to Target Lesion Failure (TLF) rate at 12 months. A total of 1859 subjects will be enrolled at approximately 100 study sites Europe and APAC. Subjects will be randomized in a 2:1 ratio to DREAMS 3G or Xience. Clinical follow-up visits will take place at 1, 6, 12 and at 2-, 3-, 4- and 5-years post procedure. ;
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