NCT03820622

The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions

Comparison of the Safety and Efficacy Between Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR) and Paclitaxel-Eluting Balloon (Bingo) in Coronary Bifurcation Lesions: A Prospective, Multicenter, Randomized, Controlled Trial (BEYOND II)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: CCRF Inc., Beijing, China · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide the clinical data for the formal application in China and for the approvement of China marketing.

Detailed 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 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.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)	patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
DEVICE	Paclitaxel-Eluting Balloon (Bingo)	patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-05-01
• Completion: 2022-10-01
• First posted: 2019-01-29
• Last updated: 2019-01-31

Locations

13 sites across 1 country: China