A Randomized Trial of a Biolimus-Coated Balloon Versus POBA in Small Vessel Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- JW Medical Systems Ltd
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- The late lumen loss
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •General exclusion criteria
- •Any patient with myocardial infarction within one month;
- •Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease;
- •Patients with cardiogenic shock;
- •Patients with left ventricular ejection fraction of less than 35%;
- •Female patients planned for or in pregnancy (or lactation) or male patients planned for impregnation;
- •Patients with the expected lifetime of no more than 1 year or potential factors of difficulty in clinical follow-up;
- •Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint, or reaching the time limit of primary endpoint but less than 3 months;
- •Patients who plans to accept selective operation within 12 months;
- •Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
Outcomes
Primary Outcomes
The late lumen loss
Time Frame: 9 months
The late lumen loss in the lesion segment 9 months after surgery