The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions

Summary

Participation Requirements

Description

This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been treated successfully, and if the side branch's stenosis is more than 70% and can be pre-dilated by POBA (plain old...

This is a prospective, multicenter, randomize, control and non-inferior study. 220 patients with bifurcation lesions will be randomized 1:1 to each group. after the main branch has been treated successfully, and if the side branch's stenosis is more than 70% and can be pre-dilated by POBA (plain old balloon angioplasty) successfully, then randomizing. the patients in the study group will be treated with paclitaxel-eluting coronary artery balloon dilatation catheter (DIOR), while those in the control group will be treated with paclitaxel-eluting balloon (Bingo). Clinical follow-up will be conducted at baseline, operation, hospital discharge, 1 month, 6 months, 9 months and 12 months after operation, and angiographic follow-up will be conducted at 9 months. The primary endpoint is late lumen loss (LLL) in the balloon dilatation coverage area of side branch of at 9 month after operation. The secondary endpoints include device success, clinical success, target lesion failure (TLF), target lesion revascularization (TLR), clinical composite endpoints and imaging endpoints. The information of adverse events, serious adverse events and device defects will be collected during the study.

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