Coronary artery disease
Conditions
Interventions
Experimental group:Coronary double guidewire scored balloon dilatation catheter
control group:High-pressure inherent guidewire coronary scoring balloon dilatation catheter
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, regardless of gender; 2. Patients with coronary artery disease, including stable and unstable angina pectoris, asymptomatic myocardial ischemia caused by coronary atherosclerotic stenosis, etc.; 3. Patients with coronary artery stenosis confirmed by imaging examinations and suitable for PCI treatment; 4. Voluntarily sign the informed consent form and show good compliance with the program. 5. The target lesion diameter stenosis is >=70% or >=50% with evidence of ischemia; 6. The reference vessel diameter of the target lesion is 2.00mm ~ 4.00mm, and the length of the target lesion is <=30mm; 7. For patients with multiple lesions, only one lesion is selected as the target lesion in this trial. If the target lesion and non-target lesion are treated at the same time, the target lesion and non-target lesion must be located in different vascular branches; and the non-target lesion must be treated first. After the non-target lesion has been successfully revascularized and no serious angiographic complications occur, the target lesion can be treated.
Exclusion criteria
Exclusion criteria: 1. ST-segment elevation myocardial infarction (STEMI) or cardiogenic shock within one week; 2. Coronary artery surgery within 1 month before surgery or planned coronary artery reoperation within 1 month after surgery; 3. NYHA heart function class III or IV; 4. Serum creatinine>2.5mg/dl; 5. Female patients are pregnant or lactating; 6. Patients with bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy who cannot receive anticoagulant therapy; 7. Known history of allergy to heparin, contrast agents, etc.; 8. Participated in other clinical trials before enrollment but did not reach the primary study endpoint; 9. The researcher judged that the patient's compliance was poor and could not complete the study as required. 10. Unprotected left main trunk lesions and left main trunk ostial lesions; 11. Coronary artery spasm without significant stenosis; 12. Severe vascular tortuosity and lesion angle >45 degrees; 13. Chronic total occlusive lesions; 14. Severe calcified lesions; 15. Flow-limiting dissection in the target vessel (NHLBI classification type D-F); 16. Thrombus in the target lesion; 17. Aneurysm within 10mm of the target lesion; 18. Restenosis of the graft vessel after coronary artery bypass grafting; 19. Bifurcation lesions requiring stent mesh treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Minimum lumen diameter;Lumen diameter stenosis;Acute Lumen Gain;Incidence of scored balloon rupture and incarceration;Equipment operation performance evaluation;Device defect incidence; | — |
Countries
China
Contacts
Public ContactBai Ming
The First Hospital of Lanzhou University
Outcome results
None listed