Coronary artery disease
Conditions
Interventions
None listed
Sponsors
Cardiovascular center, Shinkawabashi hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients is over 80 years old. 2)Patient has clinical evidence of ischemic heart disease and/or a positive functional study. 3)Patients is an acceptable candidate for percutaneous coronary intervention and stenting. 4)Patients has been informed of the nature of the trial before procedure and agrees to its provisions and has been provided written informed consent as approved by the Institutional Review Board(IRB) or equal one of the respective investigational site. Or post procedual agreement is acceptable only if its approved by the IRB.
Exclusion criteria
Exclusion criteria: 1)Limited Life expectancy within 12months. 2)Inability to comply with the required IFU antiplatelet regimen. 3)Ejection Fraction<30%. 4)Unprotected LMT disease. 5)Chronic Total Occulution. 6)The lesions in all native coronary arteries, LCX/LAD/RCA should be amenable to PCI. 7)Severe valvular disease. 8)Renal Failure. 9)Taking Warfarin Potassium. 10)Planed PCI of any vessel within 30 days post-index procedure and/or planed PCI of the target vessel(s) within 12 months post-procedure. 11)Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating (e.g.PC polymer) or a sensitivity to contrast media, which cannot be adequately pre-medicated. 12)Acute myocardial infaction with cardogenic shock. 13)Previous stenting in the target vessel(s). 14)Prior to enrollment in this study, if a surgical or any procedure is anticipated that would require early discontinuation of 3-month antiplatelet therapy. 15)Patient is not an acceptable candidate for PCI at a physician's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACCE (Death, myocardial infarction, cerebrovascular accident, target lesion revascularization, target vessel revascularization) | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurence of bleeding complications, stent thrombosis, the duration of dual antiplatelet agents. | — |
Countries
Japan
Outcome results
None listed