Ischemic heart disease
Conditions
Interventions
Implantation of TCD-10023
Implantation of Xience
Sponsors
Terumo Europe N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is  18 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. The target lesion(s) or target vessel(s) meet(s) all the following criteria: a) The stenosis of target lesion(s) is ≥ 50% by visual estimation; b) The target lesion can be covered by a maximum of two stents, except in bailout situation; c) The target vessel reference diameter must be suitable by visual estimation for treatment with stents between 2.5 and 4.0 mm; 6. 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; 7. The patient is willing and able to comply with all specified follow-up evaluations; 8. Patient is affiliated to social security or equivalent system (only for France).
Exclusion criteria
Exclusion criteria: 1.not a suitable candidate for DAPT, 2.known allergy to sirolimus, everolimus, 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.The patient has 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. n 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.under judicial protection (only for France) Additional Exclusion criteria for COHORT A 1.not less than 20 years old (in Japan only), 2.Target vessel reference D requires stent of 4.0 mm D (in Japan only), 3.AMI within 48 hours before baseline procedure, 4.Previous PCI with stenting (within 30 days), 5.Previous stenting within the TL, 6.refuse a blood transfusion, 7.a widespread peripheral vascular disease that would interfere with vascular access, 8.The TL(s) has any of the following characteristics, a)Bifurcation lesion that need stenting of main and side branch, b) Ostial lesion, c) TL is located in or supplied by an arterial or venous bypass graft, d) TL would require vessel preparation other than balloon-predilatation, 9.TL is located in left main trunk, 10.More than one lesion per vessel and more than 2 vessels disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Target Lesion Failure (TLF), a device oriented composite endpoint (cardiac death and MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularisation (TLR)) at 9 months post stent implantation for COHORT A and COHORT C | — |
Countries
Japan,Asia(except Japan),Europe
Contacts
Public ContactKazuhisa SENSHU
Terumo Europe N.V. European Medical and Clinical division
Outcome results
None listed