ST-elevation Acute Myocardial Infarction
Conditions
Interventions
Cobalt Chromium Everolimus-eluting Stent System
Sponsors
Nonprofit Organization Nakanihon PCI society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with STEMI who are able to undergo CoCr-EES implantation. 2)Patients with no history of PCI in the target vessel 3)Patients who are 20 or older at the time of informed consent 4)Patients who provided written informed consent by himself/herself 5)Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES 6)Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended 7)Patients who meet all the following vascular inclusion criteria i.Patients with target lesion in native coronary artery ii.Patients with visual maximum vessel diameter of the target stent site in target lesion 8)Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel 9)Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.
Exclusion criteria
Exclusion criteria: 1)Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study. 2)Patients presenting with cardiogenic shock 3)Patients for whom 9-month, 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account) 4)Patients with responsible lesion in left main trunk 5)Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit 6)Patients on hemodialysis 7)Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.) 8)Patients who are below the age of 20 9)Women who were positive in pregnancy test or wish to become pregnant during study duration 10)Patients who newly developed AMI attributable to the prior stented site 11)Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES 12)Patients diagnosed with hepatic insufficiency 13)Patients with target lesion in saphenous vein graft 14)Patients with active malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) and TLR associated with the target vessel. | — |
Secondary
| Measure | Time frame |
|---|---|
| MI (QMI and Non-QMI) at 9 months and 36months Any TLR at 9 months and 36months Any TVR at 9 months and 36months Death (All-cause death and Cardiac Death) at 9 months and 36months MACE (Cardiac death, MI and TLR) at 9 months and 36months Definite or Probable stent thrombosis defined by Academic research consortium (ARC) | — |
Countries
Japan
Contacts
Public ContactYoshinori Yasaka
Hyogo Brain and Heart Center Cardiology
Outcome results
None listed