Calcified Atherosclerotic Lesion in Coronary Arteries treated by Cobalt Chromium Everolimus-eluting Stent System
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000021055
- Lead Sponsor
- onprofit Organization Nakanihon PCI society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 400
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.