Japan Unprotected Left Main Coronary artery Disease PCI Strategy On New Generation Stents
- Conditions
- Coronary Artery Disease
- Registration Number
- JPRN-UMIN000004759
- Lead Sponsor
- on-profit organization Associations for Establishment of Evidence Interventions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 750
Not provided
1. Patients who can not fully understand the contents of informed consent of this study 2. Patients who can not provide informed consent because of their mental retardation or language disorder 3. Patients who cannot be followed up for 2 years after the completion of the stent placement 4. Patients who had previously received PCI or coronary artery bypass graft (CABG) for left main coronary artery (LMCA) disease 5. Patients who are scheduled to undergo cardiac surgery 6. Patients who are enrolled in an ongoing registry or clinical trial. Except for a post-marketing study (PMS) that will not influence the result of this study 7. In principal, patients who have participated or are scheduled to participate in another clinical trial related to cardiac blood vessels before completion of the 2-year follow-up period of this study 8. Patients who have a life expectancy of less than 3 years because of a concomitant disease at enrollment 9. Patients who are on home oxygen therapy (HOT) 10. Patients with a serious valvular disease 11. Patients who are on dialysis treatment 12. Patients with severe renal dysfunction (serum creatinine ≥ 2.0 mg/dL) 13. Patients with a low left ventricular ejection fraction of less than 30% 14. Patients with acute myocardial infarction or CK (CPK) levels exceeding twice the institutional upper limit of normal 15. Patients with chronic total occlusions (CTO) in the LMCA 16. Patients who are considered to require a protection device 17. Patients who are confirmed to have an allergy or hypersensitivity to everolimus, acrylic polymer, fluoropolymer or cobalt chrome alloy L-605 18. Patients who have side effects of antiplatelet agents or anticoagulants 19. Nursing women or those of childbearing potential whose pregnancy test conducted within 14 days before the procedure was positive 20. Patients disqualified from participation by the investigator/sub-investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure
- Secondary Outcome Measures
Name Time Method