To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.
The prospective, multicenter, open-label, randomized clinical study is designed to verify the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter in the application of dilatating coronary artery stenosis during PCI in comparison with a similar product on the market. The study is planned to enroll 198 subjects, who are randomly assigned to the test group (99 cases) and the control group (99 cases).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
198
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Wedge NC Scoring Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure.
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product on the market in the control group, subsequently completing the remaining procedure.
Dongguan People's Hospital
Dongguan, Guangdong, China
Dongguan Tongwah Hospital
Dongguan, Guangdong, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Procedure Success Rate
Procedure success is defined as the target lesion residual stenosis ≤30% right after PCI, without death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting (CABG) during postoperative hospitalization.
Time frame: before discharge or within 3 days after the procedure
Clinical Success Rate
Clinical success is defined as the composite endpoint of no Major Adverse Cardiovascular Events (MACE) at follow-up, including cardiac death (also considered cardiac death if the cause of death is uncertain), target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)
Time frame: 30-day follow-up after procedure
Device Procedural Success Rate
The following conditions need to be met for the successful balloon dilatation of stenotic lesions: 1. Successful delivery, inflation, deflation, and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the study balloon
Time frame: Immediately after procedure
Minimum Luminal Diameter (MLD)
The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA).
Time frame: Immediately after procedure
Percent of Diameter Stenosis(%DS)
%DS = (RVD - MLD) / RVD × 100%, MLD refers to the immediately postoperative minimum luminal diameter, RVD refers to the reference vessel diameter.
Time frame: Immediately after procedure
Acute Lumen Gain (ALG)
ALG = immediately postoperative MLD - preoperative MLD
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Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
...and 1 more locations
Time frame: Immediately after procedure
Balloon Slippage Rate
Balloon slippage is defined as a forward or backward movement of the balloon of at least 3mm during its inflation at the lesion site
Time frame: Immediately after procedure
Surgical complication
Incidence of Complications in a Single Operation
Time frame: Day 0
Rate of Adverse Events
Adverse events include death (cardiogenic death or non-cardiogenic death), acute myocardial infarction (Q wave or non-Q wave), target lesion revascularization (TLR), target vessel revascularization (TVR), other cardiac surgery and other cardiac adverse events, etc
Time frame: Month 3