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Clinical Trial Summary

This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04953117
Study type Interventional
Source Lepu Medical Technology (Beijing) Co., Ltd.
Contact Ting Zhang
Phone +86-010-80120666
Email ting_zhang@lepumedical.com
Status Recruiting
Phase N/A
Start date March 10, 2021
Completion date April 2023

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