This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.
This trial is a prospective, multicenter, randomized controlled clinical trial. 200 subjects are expected to be recruited in 7 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint is the acute lumen gain. All subjects receive clinical follow-up during hospitalization and 30 days after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The principle of Non-slip Balloon Catheter in dilating stenotic lesions is mechanical extrusion of the vessel through the balloon, resulting in irregular rupture of atheromatous plaque and enlargement of the lumen.
The Lacrosse® NSE is an angioplasty catheter with 3 longitudinal elements attached directly proximal and distal to the balloon that produces 3 endovascular surgical incisions during balloon dilation.
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGAcute Lumen Gain
Acute lumen gain is defined as the difference in the minimum lumen diameter of the target lesion before and after dilatation with the study balloon catheter (Microport or NSE Coronary Dilatation Catheter) as measured by QCA. (Acute lumen gain = minimum lumen diameter measured after dilatation with the study balloon catheter - minimum lumen diameter measured before dilatation with the study balloon catheter, AG=MLD post - MLD pre)
Time frame: Baseline procedure
Device success
Device success is defined as successful delivery, inflation, deflation, and withdrawal of the study balloon catheter with \< 50% diameter stenosis of the lesion after dilatation.
Time frame: Baseline procedure
Lesion success
Lesion success is defined as a target lesion with ≤ 30% residual stenosis and TIMI flow grade of 3 after treatment with any interventional method.
Time frame: Baseline procedure
Procedural success
Procedure success is defined as having a target lesion with ≤ 30% diameter residual stenosis and TIMI flow grade of 3 after PCI procedure while the device was successful. There were no deaths, target vessel revascularization, or myocardial infarction during hospitalization (up to 7 days after baseline procedure).
Time frame: During hospitalization (up to 7 days after procedure)
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