The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..
This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
160
To treat Coronary artery disease
To treat Coronary artery disease
Immediate lumen acquisition
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
Time frame: during the procedure
Rate of device success
Proportion of patients who meet the success criteria. Success criteria be defined as the residual stenosis of the target lesion is less than 50% after balloon dilatation and the balloon delivery system is successfully withdrawn
Time frame: during the procedure
Rate of clinical success
Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization
Time frame: from procedure to discharge ( to the 7th day after procedure)
Incidence of related complications
Including acute occlusion, vasospasm, vascular rupture, branch or collateral occlusion, subacute stent thrombosis, intimal tear, dissection, etc.
Time frame: 30 days after balloon dilatation
% change of clinically meaningful laboratory tests
Record the change of clinically meaningful laboratory tests
Time frame: 30 days after procedure
Number of adverse events
Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge
Time frame: 30 days
Number of device related composite endpoint
Including TLF, Cardiac Death, TV-MI and ID-TLR
Time frame: 30 days
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Number of patient oriented composite endpoint
Including all cause death, MI, TLR, TVR, Revascularization of any coronary arteries and thrombus at the lesion.
Time frame: 30 days
Total time of device operation performance
Push capacity, passing capacity and withdrawal capacity
Time frame: 30 days