Coronary heart disease
Conditions
Interventions
Coronary angiography combined with IVUS guidance group:Coronary angiography combined with IVUS guidance
Only coronary angiography guidance group:Only coronary angiography guidance
Sponsors
Shaanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-80 years. 2.Asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction exceeding 1 week. 3.The vessel diameter stenosis in the target lesion is >= 70%, with a reference vessel diameter of 2-2.75mm. The target lesion must be a de-novo lesion, with a lesion length of <= 25 mm (which can be completely covered by one study drug-coated balloon), and the DCB should cover the length of the pre-treatment site and exceed the edge by 2-3mm each. 4.Suitable for percutaneous coronary intervention. 5.The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent form before performing the examination or operation specified in the protocol. 6.Willing to accept all follow-up evaluations required by the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Within one week, there are clinical symptoms and/or electrocardiogram changes that are consistent with acute myocardial infarction; 2. Allergies to the balloon/stent system or accompanying drugs used in the study; 3. Inability to dual antiplatelet therapy; 4. Expected life less than 12 months; 5. Pregnant or lactating women; 6. The subject is currently participating in another clinical trial that has not yet reached the study endpoint; 7.Cardiogenic shock, severe congestive heart failure (LVEF2.0 mg/dL (176.82)] µ Mol/L)]; 8. In stent restenosis (ISR); 9. Chronic total occlusive disease (CTO); 10. Left main trunk lesion; 11. The target vessel has extensive thrombosis; 12. Within 10mm of the edge of the coverage area of the target lesion drug balloon, stent placement or drug balloon dilation has been or is planned; 13. Severe calcification or distortion of target blood vessels hinders the passage of instruments; 14. The target lesion involves an aneurysm or is adjacent to the aneurysm (within 5 mm); 15. Target lesions with severe calcification require rotary grinding treatment; 16. Targeted lesions in bypass graft blood vessels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (MACE) at 12 months post PCI(Including cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints observed at 12 months post PCI: all-cause death, any myocardial infarction, ischemia driven target vessel revascularization.;Perioperative endpoints, including lesion success rate, clinical surgical success rate, and target vessel drug-eluting stent implantation rate; | — |
Countries
China
Contacts
Public ContactLei Liang
Shaanxi Provincial People's Hospital
Outcome results
None listed