Coronary Artery Disease
Conditions
Interventions
Drug coated balloon therapy group:After DCB treatment, dual antiplatelet therapy (DAPT) is administered for 1 month, followed by single antiplatelet therapy (preferably clopidogrel). If the patient is
DES treatment group:After DES implantation, dual antiplatelet therapy (DAPT) is administered for at least 6 months, and then the antiplatelet regimen is determined by the operator at his/her discretio
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. PCI is required according to clinical conditions (angiographic stenosis >=75% / angiographic stenosis >=50% with AngioFFR =4.0mm^2 and/or AngioFFR >0.80; 4. No hemodynamically significant dissecting hematoma (angiographic Type A or B dissection, IVUS dissection not involving the media) and TIMI flow grade 3; 5. Able to be followed up for more than 1 year and willing to cooperate with the trial follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Age 80 years old; 2. Cardiogenic shock, complicated with left main lesion, severe tortuous lesion, complex bifurcation lesion, severe calcification, total occlusion of target vessel or bypass vessel; 3. Recent (within 1 month before surgery) major surgery history or definite gastrointestinal bleeding event; Patients with allergies or contraindications to the following drugs: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, contrast medium (patients with definite contrast medium allergy such as rash can be enrolled if it can be controlled in advance with effective drugs (e.g., glucocorticoids, diphenhydramine)); 5. Female patients who are pregnant or lactating; 6. Non-cardiac comorbidities indicating life expectancy of less than 1 year; 7. Any factors that may affect follow-up or meet the criteria of other studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net Clinical Adverse Events (NACE) at 12 Months;Major Adverse Cardiovascular and Cerebrovascular Events (MACCE);Major bleeding or clinically relevant non-major bleeding at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Vessel Failure (TVF): A composite of cardiac death, target vessel MI, or target vessel revascularization;NACE, major bleeding or clinically relevant non-major bleeding, and MACCE at 36 and 60 months;All-cause death and cardiac death;MI, spontaneous MI, peri-procedural MI, and target vessel MI;Any revascularization of the target vessel/target lesion;Any revascularization of a non-target vessel/ non-target lesion;Any revascularization (ischemia-driven or all-cause);Stent Thrombosis: Classified as definite, probable, or possible.;Stroke: Including both ischemic and hemorrhagic stroke;Bleeding Events: BARC 3 or 5 bleeding, and BARC 2 bleeding; | — |
Countries
China
Contacts
Public ContactJianan Wang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed