Coronary artery disease
Conditions
Interventions
Cobalt Chromium Everolimus-eluting Stent System(CoCr-EES)
Sponsors
Nonprofit Organization Nakanihon PCI society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Patients who is 20 years of age or older at informed consent b) Patients who submit signed consent by themselves or their legally acceptable representative c) Patients who are suitable for treatment with PCI d) Patients who have calcification in stenotic lesions confirmed by CAG and are considered to be suitable for DES stenting as the best option by a treating physician e) Patients for whom Xience stent is considered suitable for treatment f) Patients with the visually measured maximum vessel diameter of =or< 2.5, =or>4.0 mm in the planned location for device implantation in the target lesion g) Patients who are considered to be possible to continue dual antiplatelet therapy for at least 6 months after Xience implantation
Exclusion criteria
Exclusion criteria: h) Patients who, apart from this study, have received or plan to receive DES other than everolimus-eluting stent in the target vessel i) Patients with acute myocardial infarction (MI) j) Patients who have experienced acute MI within 7 days before planned PCI k) Patients who are participating another on-going registry or clinical study or receiving treatment that may has an impact on endpoints of this research l) Female patients who are found to be possibly pregnant by a pregnancy test or plan to be pregnant during this study m) Patients with a past history of allergy to everolimus, polymer, or metal n) Patients with a past history of allergy to antiplatelet drugs. o) Patients who have been diagnosed as renal insufficiency. p) Patients with renal insufficiency (serum creatinine of 3.0 mg/dL or higher) or on hemodialysis q) Patients who had been diagnosed as having malignant tumor(s) in past 5 years r) A target lesion is an in-stent restenosis lesion s) A target lesion is in a graft t) Patients who have 2 indepeneded lesions in same vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) within 1 year after Xience implantation. TLF include cardiac death, target vessel related MI, clinically-driven TLR [that is with ischemic symptoms or a positive functional ischemia study or DS>70% or higher confirmed by quantitative coronary angiography (QCA)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Procedural success rate (technical success rate and clinical success rate) of Xience implantation b) Incidence of MI (Q wave MI and non-Q wave MI) at 12-month and 36 months follow-up. c) Target vessel failure (TVF) at 12months and months follow-up. d) Major adverse cardiac event (MACE) (cardiac death, MI, and TVF) at 12 months and 36 months. e) Stent thrombosis: Definite or Probable stent thrombosis according to the academic research consortium (ARC) definition. | — |
Countries
Japan
Contacts
Public ContactKenya Nasu
Toyohashi Heart Center Cardiology
Outcome results
None listed