Coronary artery disease
Conditions
Interventions
Experimental arm:Coronary artery cutting balloon developed by Suzhou Shengke Intelligent Technology Co., Ltd
Control arm:Coronary artery cutting balloon manufactured by Boston Scientific in United States
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-80 years , regardless of gender, and the hospital considers the patient to be eligible for coronary angiography; (2) Patients with stable angina, unstable angina, or old myocardial infarction or silent myocardial ischemia; (3) Reference vessel diameter is 2.00mm-4.00mm, and the lesion length = 70% or >= 50% accompanied by evidence of ischemia; (5)One or two primary coronary artery lesions that need to be treated, if there are two lesions, they must be located in different epicardial vessels; (6)Lesions that the investigator believes require the use of a cutting balloon for the target lesion, and the cutting balloon can be passed through by pre-dilation; (7)Patients who are able to understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to undergo clinical follow-up as required by the study.
Exclusion criteria
Exclusion criteria: (1) Any myocardial infarction within a week; (2) Left main coronary artery disease and lesions 45 ° angled; (8) Complete occlusion of blood vessels; (9) NYHA Class IV patients; (10) Patients with severe liver and kidney failure (serum creatinine>200umol/L) or undergoing hemodialysis treatment; (11) Patients who cannot undergo coronary artery bypass graft (CABG) surgery in an emergency; (12) The disease can be difficult to treat and evaluate; (13) Heart transplant patients; (14) Subject has a life expectancy of less than 12 months; (15) Patients with bleeding tendency, history of peptic ulcer in active; (16) History of allergies to heparin, contrast agents, etc; (17) Subject has participated in other clinical trials within the past 1 month; (18) Individuals who have participated in other drug or medical device trials but have not reached the primary study endpoint time limit; (19) Interventional doctors predict that the risk of interventional surgery is extremely high or other cases that should be excluded; (20) Investigator have determined that patients have poor compliance and are unable to complete as required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute gain in lumen diameter;Procedure success rate;Intraoperative complication rate;Number of target lesion faliure;Patient-oriented composite endpoint; | — |
Countries
China
Contacts
Public ContactLei Song
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed