Coronary Artery Disease
Conditions
Interventions
6 months DAPT: DAPT consisting of aspirin and thienopyridine will be discontinued at 6 months after PCI.
18 months DAPT: DAPT consisting of aspirin and thienopyridine will be continued for 18 months a
Sponsors
NPO Associations for Establishment of Evidence in Interventions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient between 20 and 80 years. 2. Patient who is clinically indicated for PCI. 3. Patient who has agreed to undergo all clinical FUs listed in the present protocol. 4. Patients who can receive antiplatelet agents for 6 months after stenting. 5. Patient who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent.
Exclusion criteria
Exclusion criteria: 1. Patient with cardiogenic shock. 2. Patient who needs continuous treatment of thienopyridine. 3. Patient with a history of stent thrombosis. 4. Patient who is confirmed to have an allergy or hypersensitivity to sirolimus or substance with a structure similar to biolims-A9 (ex., tacrolimus, everolimus). 5. Patient who is confirmed to have an allergy or not to have a tolerability to antiplatelet agents, anticoagulants or a contrast medium. 6. Patient who is confirmed to have an allergy or hypersensitivity to materials of Nobori biolims A-9 eluting stent. 7. Patient with a hemorrhagic predisposition or a history of coagulation abnormality. 8. Patient whose left ventricular ejection fraction (LVEF) is < 30%. 9. Patient under pregnancy (present, suspected or planned). 10. Patient who has a life expectancy of less than 12 months. 11. Patient who has an active bleeding. 12. Patient who is scheduled to undergo treatment requiring discontinuation of an antiplatelet agent. 13. Patient with a verified history of cerebral apoplexy or intracranial bleeding within 6 months before stenting. 14. Patient who is scheduled to undergo stent treatment in other lesions after the 30th day of the registration. 15. Patient who is received the follow-up observation. 16. Patient who has unprotected LMT lesion (50%>%DS). 17. Patients disqualified from participation by the investigator/sub-investigator. 18. Patient who underwent stent treatment with DES 6 months prior to the conduct of index PCI. 19. Lesions located within the saphenous venin graft (SVG). 20. Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Nobori biolimus-A9 stent. 21. Lesions of in-stent restenosis in previously deployed DES.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of net adverse clinical and cerebral events (NACCE) at clinical FU between 6 to 18 month after stenting. NACCE: NACCE is defined as a composite endpoint consisting of death from some causes (including cardiac death and noncardiac death), MI (including Q-wave MI and non-Q-wave MI), CVA, and major bleeding (as per the definitions listed in the revised version of REPLACE-2, GUSTO and BARC). | — |
Countries
Japan
Contacts
Public ContactTeruhisa Kiguchi
NPO Associations for Establishment of Evidence in Interventions NIPPON Trial support center
Outcome results
None listed