To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter.
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.
Device Procedural Success Rate
Time frame: one hour
Clinical treatment success rate
Time frame: one hour
acute lumen gain,ALG
Immediate lumen gain is defined as: ALG = the immediate minimum lumen diameter after balloon dilation - the minimum lumen diameter before the operation.
Time frame: one hour
The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery
Time frame: 30 days
The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery
Time frame: 30 days
The incidence of major adverse cardiac events (MACE) within 30 days after surgery
Time frame: 30 days
Evaluation of Device Performance
CRF
Time frame: one hour
The incidence rate of medical device-related complications
Time frame: one hour
The incidence rate of device defects
Time frame: one hour
The incidence rate of adverse events and serious adverse events
Time frame: thirty days
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