Coronary artery disease
Conditions
Interventions
prolonged DAPT:P2Y12 inhibitor + aspirin
standard DAPT:aspirin
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: 1. The subjects must be over 18 years old; 2. The subjects had evidence of ischemia and were suitable for PCI; 3. The subjects must be qualified candidates for CABG surgery; 4. Women of childbearing age (18-49 years old) can participate in this study only if they are confirmed not pregnant by the doctor in charge before stent implantation; 5. The female subjects of childbearing age did not have lactation plan during the lactation period and one year after the starting operation; 6. The subjects agreed not to participate in other clinical trials before reaching the end of this trial; 7. Subjects / legally authorized representatives understand the purpose and procedure of the trial and sign informed consent voluntarily. 8. The target lesion must be located in the autogenous coronary artery, and% DS >= 50% by visual or quantitative evaluation; 9. The Dmax of target lesions measured by on-line QCA was greater than or equal to 2.75mm and = 2.75mm and <= 3.5mm.
Exclusion criteria
Exclusion criteria: 1. Patients with cardiogenic shock; 2. The left ventricular ejection fraction (LVEF) measured by preoperative transthoracic echocardiography or intraoperative left ventricular contrast quantitative analysis was less than 30%. The LVEF measured within 6 months before operation was effective in patients with stable coronary heart disease; 3. Subjects with high risk of bleeding, or bleeding tendency, history of coagulation disorders; major gastrointestinal bleeding within 6 months; severe hematuria; contraindications of antiplatelet preparation and anticoagulant therapy, unable to carry out antithrombotic therapy; 3; 4. Subjects had allergic / hypersensitive reactions to aspirin, heparin, clopidogrel and other P2Y12 inhibitors; 5. The subjects have some allergies or contraindications which can not be completely cured before treatment and inhibit the instrument materials and degradation products (rapamycin, L-polylactic acid, racemic polylactic acid, lactic acid lactide, lactic acid); 6. The subjects were allergic to contrast media and could not be cured completely before treatment; 7. Any surgical treatment requiring general anesthesia or interruption of aspirin and / or P2Y12 inhibitors is planned within 365 days after surgery; 8. Subjects who are expected to need staged PCI for target vessels; 9. The life expectancy of subjects is less than 5 years; 10. Subjects participating in clinical trials of other drugs or devices fail to reach the main research end point; 11. Subjects were unable or unwilling to participate in the trial. 12. Subjects who need to receive warfarin or other new oral anticoagulant drugs; 13. Patients who received PCI or CABG one year before the intervention; 14. Patients with the target lesion located in the left main trunk; 15. Patients with target lesion of right coronary artery (RCA) located at aortic opening (within 3 mm of aortic junction of RCA); 16. The target lesion was located within 3 mm of the origin of left anterior descending artery (LAD) or left circumflex artery (LCX); 17. True bifurcation lesions expected to require dual stenting (Medina classification 1,1,1) 18. The anatomical structure near the target lesion or within the lesion may hinder the delivery of xinsorb The extreme reverse arch (>= 90 degrees in the proximal or inner part of the target lesion); The proximal or inner curvature of the target lesion (>= two 45 degrees angles); Moderate or severe calcification near or inside the target lesion; The target lesion involved muscle bridge; 23. Patients who need both metal and bioabsorbable stents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE;BARC type 3 to 5 bleeding events; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed