Ischemic heart disease
Conditions
Interventions
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) and acceptable candidate for coronary artery bypass grafting (CABG). 3) Clinical evidence of ischemic heart disease and/or a positive functional study, stable angina pectoris (Canadian Cardiovascular Society Classification (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or silent ischemia. 4) The target lesion(s) or target vessel(s) meet(s) all the following criteria; a) The target lesion is a single de novo lesion or restenotic post-PTCA (non-stented) lesion in one or two native coronary artery. b) The stenosis of target lesion(s) is > 50% and < 100% (by visual estimation). c) The target lesion length must be < 25 mm. d) The target reference vessel diameter must be (by visual estimation) suitable for treatment with stents between 2.5 and 4.0 mm. 5) Patient has been informed of the nature of the study, understands the study requirements and 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.
Exclusion criteria
Exclusion criteria: 1) Most recent LVEF is < 25% 2) Known allergies to aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent or Sirolimus 3) A platelet count is < 100K or > 700K 4) WBC count is < 3.5K 5) Evidence of an ST-segment elevation acute MI or Non-ST segment elevation MI with positive Troponin within 72h of the intended treatment 6) Previous PCI 7) Presence of any other significant lesion of > 50% stenosis anywhere within the target vessel (TV) 8) Significant lesions in any non-TV that will require interventional treatment, within 30 days post-procedure 9) Planned future interventional procedure in the TV is not allowed 10) The target lesions requires treatment with a device other than PTCA balloon prior to stent placement 11) Previous stenting anywhere within the TVs 12) TV has evidence of thrombus 13) Excessive tortuousity of the TV proximal to the target lesion (TL) 14) Either of the following characteristics in the TLs a) Ostial TL or bifurcation lesion b) TL involves a side branch c) TL has excessive tortuousity d) Moderate to severely calcified lesion which can not be successfully predilated e) TL is located in or supplied by an arterial or venous bypass graft f) Significant stenosis proximal or distal to the TL g) A complete occlusion 15) TL is located in left main trunk. 16) Stroke or transient ischemic attack within the prior 180d 17) Active peptic ulcer or upper GI bleeding within the prior 180d 18) The PT (patient) has bleeding hemorrhagic diathesis or coagulopathy. 19) The PT will refuse a blood transfusion 20) The PT has a widespread peripheral vascular disease 21) Acute or chronic renal dysfunction 22) The PT requires multiple stent implantations for a tandem lesion 23) Life expectancy <1Y 24) PT is currently participating in other clinical studies 25) In the investigators opinion PT has co-morbid conditions that could limit the PTs ability to participate in the study 26) PT in cardiogenic shock 27) Female of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Loss at 6 months | — |
Countries
Europe
Outcome results
None listed