Coronary artery stenosis
Conditions
Interventions
experimental group:Lepu Non-Slip Element Coronary Dilatation Catheter
control group:NSE Coronary Dilatation Catheter
Sponsors
Beijing Luhe Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria:1. 18= age= 85 years old, male or female; 2. Patients with coronary atherosclerotic heart disease (stable angina, unstable angina, non-acute myocardial infarction or asymptomatic myocardial ischemia) requiring coronary intervention; 3. Able to understand the purpose of the trial, participate voluntarily in and sign the informed consent form, and willing to conduct clinical follow-up as required; Image Inclusion Criteria:1. coronary artery stenosis =70% or =50% (visually) with evidence of ischemia; 2. Vessel diameter (visually) between 2mm and 4mm; 3. Lesions that the investigator determines that the plain balloon cannot complete the expansion or the disorderly expansion likely to cause dissection and thus increase the risk of acute occlusion of blood vessels; 4. Each patient is allowed to have 1 or 2 target lesions that need to be treated; 5. Non-target lesions need to be successfully treated prior to target lesion treatment (TIMI flow grade 3).
Exclusion criteria
Exclusion criteria: General Exclusion Criteria:1. Any myocardial infarction within one week; 2. Patients with acute thrombosis requiring thrombolysis or thrombectomy; 3. Severe heart failure (NYHA IV); 4. Patients with severe liver or kidney failure or undergoing hemodialysis treatment; 5. Coronary atherectomy, laser, double guidewire balloon, mastoid balloon, and cutting balloon are planned for the target lesion or thrombus aspiration management; 6. Patients who are allergic to other anticoagulant and antiplatelet drugs such as contrast agent, aspirin, heparin sodium, clopidogrel, etc.; 7. Cerebrovascular accident within the past 6 months; 8. Active peptic ulcer or active gastrointestinal bleeding within the past 6 months; 9. Pregnant or lactating women; 10. Life expectancy of less than 12 months; 11. Patients who have participated in clinical trials of other devices or drugs in the past 1 month and have not reached the primary study endpoint; 12. The investigator judged that the patient had poor compliance and was unable to complete the study as required; 13. Other patients who should be excluded in the opinion of the investigator; Image Exclusion Criteria:1. coronary spasm without organic stenosis; 2. Graft vascular disease; 3. Unprotected left main lesions; 4. Lesions that are extremely bent and angular so that the guidewire or balloon cannot pass; 5. CTO lesions; 6. Stent covered bifurcation lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| device success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;acute gain in lumen diameter;Target lesion failure composite endpoint;Complications of surgery;Instrument handling performance;Cardiovascular clinical composite endpoint;adverse event; | — |
Countries
China
Contacts
Public ContactZhai Guangyao
Beijing Luhe Hospital Affiliated to Capital Medical University
Outcome results
None listed