Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Vascular
With
Medtronic Japan Co., Ltd.
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
Informed consent
Patient agrees to comply with specified follow-up evaluations at same investigational site
Single target lesion or two target lesions located in separate coronary arteries
De novo lesion(s) in native coronary artery(ies)
Target lesion(s) ≤ 27 mm in length
Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
You may not be if
Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; white blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) \> lab upper limit of normal)
Previous PCI of target vessel(s) within 9 months prior to the procedure
Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
History of stroke or transient ischemic attack (TIA) within prior 6 months
Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
Inability to comply with required trial antiplatelet regimen
Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
