NCT04953117

A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DCB of Lepu Medical(dimeter≥2.00 mm)	subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)
DEVICE	Restore DEB	subjects receiving Restore DEB
DEVICE	DCB of Lepu Medical(dimeter<2.00 mm)	subjects receiving DCB of Lepu Medical(dimeter\<2.00 mm)

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-06-01
• Completion: 2023-04-01
• First posted: 2021-07-07
• Last updated: 2021-07-07

Locations

14 sites across 1 country: China