Coronary Artery Disease
Conditions
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.
Interventions
DEVICEBiolimus
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus
DEVICEPowerline
103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline
Sponsors
JW Medical Systems Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Diameter: 2.0mm, 2.25mm, 2.5mm, 2.75mm Length: 10mm, 15mm, 20mm, 25mm, 30mm
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria 1. Subjects with stable angina pectoris, unstable angina pectoris, old myocardial infarction or silent myocardial ischemia with objective evidence; 2. Subjects at the age between ≥18 and ≤75 years old; 3. Subjects without contraindications of coronary revascularization (PCI or CABG); 4. Subjects are willing to participate in the study, sign informed consent form, and accept angiography follow-up at 9 months after operation as well as clinical follow-up after operation and at 30 days, 6 months, 9 months and 12 months after operation. Radiography inclusion criteria 1. Target lesion is primary in-situ coronary artery disease, located on 1 or 2 different coronary artery vessels, with no more than 1 target lesion on each coronary artery vessel (in case of lesion on two vessels, 2 target lesions are allowed at most); 2. Reference vessel diameter is between 2.0 mm and 2.75 mm (visual observation); 3. For non-target vessel lesion, interventional therapy needs to be conducted firstly (simultaneous therapy is required). After successful therapy, it is required to conduct random and target lesion treatment; 4. Preoperative diameter stenosis must be ≥70% or ≥50%, accompanied with corresponding ischemia of target vessel (visual observation); 5. Each target lesion of patients in test group and control group can only be treated with one trial device (Biolimus release coronary balloon catheter) or control device (Powerline balloon angioplasty catheter).
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The late lumen loss | 9 months | The late lumen loss in the lesion segment 9 months after surgery |
Countries
China
Outcome results
None listed