Coronary Artery Disease Clinical Trial
Official title:
Assess the Safety and Efficacy of Lepu® Drug Coated Balloon Versus RESTORE® Paclitaxel Eluting Balloon for the Treatment of Coronary Small-vessel Disease: a Prospective, Multicenter, Randomized, Controlled Trial
This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
This study include a small vessel cohort and a very small vessel cohort. In the small vessel cohort, patients with visually estimated reference vessel diameters(RVDs)≥2.0 and ≤2.75mm were randomly assigned to the Coronary Drug Coated Balloon Catheter Used in Small Vessels of Lepu Medical or the Restore DEB in a 1:1 ratio. The study was powered to detect the noninferiority of the DCB of Lepu Medical versus the Restore DEB for a primary endpoint of in-segment late lumen loss(LLL) at 9 months. In the very small vessel cohort, patients with RVD≥1.75 and<2.0mm were treated with the DCB of Lepu Medical of an appropriate size. All subjects will been followed up for 2 years to observe the occurrence of adverse events, so as to make an accurate and reliable evaluation of the safety of drug coated balloon catheters for coronary small vessels. ;
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