Coronary heart disease
Conditions
Interventions
experimental arm:APT generated Non-slip balloon dilatation catheter
control arm:NSE Coronary Dilatation Catheter
Sponsors
Jiangxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 - 80 years 2. Coronary atherosclerotic heart disease Patients to be treated with PCI 3. ? lesion stenosis = 70%; or? Evidence of myocardial ischemia in conjunction with =50% lesion stenosis 4. Only one target lesion is to be treated with the tested product; up to two non-target lesions must be located in different vessels from the target lesion and the target lesion must be intervened after the non-target lesion has been successfully treated. 5. Reference vessel diameter of the target lesion between 2.0-4.0 mm, target lesion length = 30 mm 6. Signing the informed consent form
Exclusion criteria
Exclusion criteria: Exclusion Criteria - Non-Imaging 1. It is proposed to treat the target lesion with any of the Rotational catheters, laser ablation catheters, dual guide wire balloons, scoring balloons, cutting balloons or shock wave balloons simultaneously. 2. Acute myocardial infarction within 1 week 3. History of stroke within 6 months 4. Active peptic ulcer or active gastrointestinal bleeding within 6 months 5. Left ventricular ejection fraction 221umol/L or on haemodialysis; 7. Serious allergies or contraindications to antiplatelet, anticoagulant or contrast agents; 8. Elective surgery requiring discontinuation of antiplatelet drugs planned within 1 month ; 9. Dementia, mental abnormality or a history of mental illness that prevents them from cooperating autonomously; 10. Pregnant or breastfeeding women; 11. being involved in other interventional clinical trials; 12. Not suitable for inclusion in this trial as judged by the investigator. Exclusion Criteria - Imaging 1) Left main disease 2) Severe three-vessels disease requiring revascularization. 3) The following indicated only to the target lesion or target vessel: ? Aortic-coronary ostium lesions, chronic occlusive lesions or graft lesions (ii) Bifurcation lesions that meet any of the following criteria: a. require 2 or more stents; b. have a collateral vessel diameter >2mm and require pre-dilation (iii) target lesions that cannot be passed by other interventional devices prior to application of the tested product ? The target vessel exists blood flow restricted dissection(NHLBI type C and above) or perforation prior to dilatation by the test product ? Thrombus attached to the target lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| acute gain in lumen diameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| device success rate;acute procedure success rate;Number of target lesion faliure[ Time Frame: 30 days ];Number of serious adverse event;Number of serious adverse event;Number of device defect; | — |
Countries
China
Contacts
Public ContactHong Lang
Jiangxi Provincial People's Hospital
Outcome results
None listed