This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.
This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain \[QCA analysis\], surgical success rate, in-hospital major adverse cardiac event \[MACE\] incidence rate, target lesion failure \[TLF\] incidence rate within 30 days after surgery, patient-related composite endpoints \[PoCE\] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the Coronary artery scoring balloon dilation catheter treatment group.
One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the ScoreFlex NC Coronary Dilatation Catheter treatment group.
Rate of successful device usage
The investigational device was successfully delivered to the intended target lesion, dilated, deflated, and retrieved smoothly; After balloon angioplasty with the investigational device, the residual stenosis of the target lesion diameter was \<50%.
Time frame: 1hour
Rate of success of the surgery
The success of the surgery is defined as on the basis of successful use of the instrument, the residual stenosis of the target lesion diameter after PCI is ≤ 30% and TIMI blood flow is grade 3, and no MACE occurs in the hospital.
Time frame: 3 days
Incidence of in-hospital MACE
MACE includes cardiac death, target vessel myocardial infarction, and target lesion re-vascularization
Time frame: 30 days
Incidence of PoCE within 30 days after surgery
PoCE includes all-cause mortality, all MIs, and any re-vascularization
Time frame: 30 days
The lumen is obtained immediately
The lumen is obtained immediately (QCA analysis)
Time frame: 1hour
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