Ischemic heart disease
Conditions
Interventions
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is >=20 years old; 2. Patient is eligible for percutaneous coronary intervention (PCI) using DES; 3. Patient is acceptable candidate for CABG; 4. Patient has clinical evidence of ischemic heart disease and/or a positive functional study. Stable or unstable angina pectoris, or documented silent ischemia; 5. Patient has been informed of the nature of the study, understands the study requirements, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site; 6. The patient is willing and able to comply with all specified follow-up evaluations; 7.The target lesion or target vessel meet all the following criteria: a) The significant stenosis of target lesion needs to be treated; b) The target lesion can be covered by one stent, except in bailout situation; c) The target vessel reference diameter must be suitable by visual estimation for treatment with 2.25 mm stents;
Exclusion criteria
Exclusion criteria: 1.Not a suitable candidate for DAPT, 2.Known allergy to Limus family drugs, cobalt, chromium, nickel, or contrast agent, 3.Most recent LVEF of the patient is not more than 25%, 4.PLT count is less than 100K cells/mm3 or more than 700K cells/mm3, 5.WBC count is less than 3,500 cells/mm3, 6.Cerebral hemorrhage within 180 days prior to the baseline procedure, 7.Active peptic ulcer or upper GI bleeding within 180 days prior to the baseline procedure, 8.Bleeding diathesis or coagulopathy, 9.Any planned future PCI, 10.Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints, 11. In the investigator's opinion, patient has (a) co-morbid conditions(s) that could limit patients's abilibility to participate in the study, compliance with FU requiements or impact the scientific integrity of the study, 12. In cardiogenic shock, 13.Life expectancy less than 1 year, 14. Renal failure requiring dialysis, 15. Female of child-bearing potential, 16.AMI within 48 hours before baseline procedure, 17.Previous PCI with stenting (within 30 days), 18.Previous stenting within the target lesion, 19.Will refuse a blood transfusion, 20.A widespread peripheral vascular disease that would interfere with vascular access, 21.The target lesion and non-target lesion(s) has any of the following characteristics, a)Bifurcation lesion that need stenting of main and side branch, b)Ostial lesion involving the origin of the coronary artery within the first 3 mm, c) Located in or supplied by an arterial or venous bypass graft, d) Require vessel preparation other than balloon-predilatation, e) Left main trunk, f)Chronic total occlusion, 22. There are three or more non-target lesions other than one target lesion. 23.A non-target lesion is located within 15 mm visually from a target lesion. 24. The non-target lesion that need more than 1 stent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Major Adverse Cardiac Events (MACE), a device oriented composite endpoint (cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularization (TLR)) at 9 months post stent implantation | — |
Countries
Japan
Contacts
Public ContactTerumo Corporation
Terumo Corporation Clinical Development Depertment
Outcome results
None listed