Coronary Atherosclerosis
Conditions
Interventions
Test group:Treatment with the Cutting Balloon Catheter Manufactured by Shenzhen Shunmei Medical Co., Ltd.
Control group:Treatment with the Cutting Balloon Catheter Manufactured by Boston Scientific Corporation
Sponsors
Teda International Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 80 years (inclusive), regardless of gender; (2) Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia; (3) Target lesion with a reference vessel diameter of 2.00–4.00 mm and lesion length =20 mm); (5) Target lesion with visually assessed diameter stenosis >=70% or >=50% accompanied by ischemic evidence; (6) Lesion deemed by the investigator to require cutting balloon therapy and achievable for balloon passage after pre-dilation; (7) Patients capable of understanding the trial’s purpose, voluntarily participating, signing informed consent, and willing to comply with clinical follow-up requirements.
Exclusion criteria
Exclusion criteria: (1) Unprotected left main coronary artery lesions; (2) Ostial lesions or bifurcation lesions requiring intervention; (3) Evidence of acute myocardial infarction within 7 days; (4) Chronic total occlusion (CTO) lesions; (5) Target lesions with severe angulation (>45°); (6) Non-target lesions requiring treatment exceed 2 sites, or non-target lesions cannot undergo intervention prior to the target lesion or have failed intervention; (7) Angiographically visible thrombus in the target lesion; (8) Severe hepatic or renal dysfunction (serum creatinine >200 µmol/L) or patients undergoing hemodialysis; (9) Severe heart failure symptoms (NYHA Class IV) or left ventricular ejection fraction (LVEF) <40%; (10) History of cardiac transplantation; (11) Life expectancy <12 months; (12) Bleeding tendency, active peptic ulcer, or intolerance to dual antiplatelet therapy; (13) Severe allergy history to heparin, contrast agents, or related substances; (14) Participation in other drug/device trials without completing primary endpoints; (15) Investigator-assessed poor compliance or inability to complete the study per protocol; (16) Pregnancy or lactation; (17) Other conditions deemed by investigators to contraindicate trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural Success Rate;Target Lesion Failure Composite;Patient-Oriented Composite Endpoint; | — |
Countries
China
Contacts
Public ContactJing Rui
Teda International Cardiovascular Hospital
Outcome results
None listed