Acute Coronary Syndrome
Conditions
Interventions
Group 1 :
Group 2:
Sponsors
Affiliated Hospital of Zunyi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. General selection criteria: (1) Aged 18-80 years old, male or female subjects; (2) The clinical diagnosis meets the 2015 European Society of Cardiology diagnostic criteria for ACS; ischemic symptoms (chest tightness, chest pain) > 20 minutes; positive troponin T, I or high-sensitivity troponin, exceeding the upper limit of normal by more than 99%; Identify culprit blood vessels; (3) Subjects who are able to understand the purpose of the trial, participate voluntarily and agree to the risks and benefits described in the informed consent document by signing the informed consent document, and are willing to accept invasive imaging follow-up; 2. Inclusion criteria for angiography: (1) The lesions are simple lesions, non-left main lesions and LAD/LCX/RCA opening lesions; (2) Lesions of single or double vessels, and the length of the lesion is less than or equal to 30 mm.
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock, acute heart failure (NYHA IV grade), combined with malignant arrhythmia, such as ventricular tachycardia, ventricular fibrillation; 2. Women who are breastfeeding, pregnant or planning to become pregnant during the study; 3. The researcher believes that the subject is not suitable to participate in this trial (such as suffering from malignant tumor); 4. Routine blood test shows that the platelet count is lower than 100 x 10^9/L, or greater than 700 x 10^9/L; 5. Subjects with bleeding tendency, contraindications to antiplatelet preparations and anticoagulant therapy, subjects who cannot receive antithrombotic therapy, or subjects who cannot tolerate 12 months of DAPT treatment; 6. History of peptic ulcer or gastrointestinal bleeding in the past 6 months; 7. Suffering from cerebrovascular accident in the past 6 months, or suffering from permanent neurological deficits that may lead to non-compliance with the experimental protocol; 8. Those who are allergic to aspirin, heparin, contrast medium, iopamidol and paclitaxel; 9. The life expectancy of the subject is less than 12 months; 10. The researcher judges that the subject's compliance is poor and cannot complete the study as required; or other reasons lead to the researcher's opinion that the subject is not suitable for inclusion; 11. Subjects who are participating in any other clinical trials, or subjects who have participated in clinical trials of other drugs or medical devices before enrollment but have not reached the time limit of the main research endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment Late Lumen Loss;Incidence of major cardiovascular adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success;Lesion success;clinical success;device oriented composite endpoints;patient oriented composite endpoints;death;myocardial infarction;target lesion revascularization;target vessel revascularization;any revascularization of coronary arteries;thrombosis;rate of binary restenosis; | — |
Countries
China
Contacts
Public ContactBei Shi
Affiliated Hospital of Zunyi Medical University
Outcome results
None listed