NCT03769623

A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, randomized, blind, parallel and superiority test study. It is planned to select 206 cases of subjects with small coronary artery vessel disease who meet the inclusion/exclusion criteria. They are randomly divide them into Biolimus release coronary balloon catheter treatment group and plain old balloon angioplasty catheter (Powerline) treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation. Follow-up with angiography is conducted at 9 months. The late lumen loss in diseased segment at 9 months after operation is the primary endpoint.

Detailed description

The study was a prospective, multicenter, randomized, blind, parallel positive control, and superiority test study, 206 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were randomly assigned to the treatment group of Biolimus and Powerline at 1:1. All subjects underwent clinical follow-up at 30 days, 6 months, 9 months, and 12 months after surgery, and angiographic follow-up at 9 months. The primary endpoint was late lumen loss at 9 months. The study will enroll 206 subjects. The sample size determination process is as follows: Sample size is calculated according to the primary endpoint, late lumen loss (LLL) in diseased segment at 9 months after operation. Through literature review, a Meta analysis combined 11 randomized and control study shows that the late lumen loss level of control group (POBA) in the treatment of small vessel disease is 0.54mm. Another Meta analysis shows that LLL after PTCA operation is 0.57±0.57mm. Clinical investigators and statisticians, according to literature and clinical practice, suppose that the LLL level of test group (DCB) in this study can be lowered to 0.32mm and the combined standard deviation of LLL of the two groups is estimated to be 0.50mm conservatively. The calculation formula of sample size for parallel design and superiority test is used. In case of taking 0.025 at singles side for inspection level, taking 80% for power (1-β), and taking 0 for superiority cut-off, conduct random grouping according to the ratio of 1:1, the require sample size of each group is calculated to be 82 cases. Considering the maximum failure rate 20% in angiography follow-up (as well as the early withdrawal and random damage caused by other reasons), the planned total sample size of both groups is 206 cases finally, including 103 cases for test group (DCB) and 103 cases for control group.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Biolimus	103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus
DEVICE	Powerline	103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline

Timeline

• Start date: 2019-06-25
• Primary completion: 2021-02-20
• Completion: 2021-04-06
• First posted: 2018-12-07
• Last updated: 2021-09-22

Locations

1 site across 1 country: China