![]() Boston Scientific Corporation, Defendant. Sustained systolic blood pressure 75 percent diameter stenosis based on visual estimate exception: planned stenting of a lesion proximal to the target lesion that can be covered by a single stent (i.e.UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA.Known history of clinically significant abnormal laboratory findings ≤ 14 days prior to enrollment, including:Įvidence of current clinical instability including the following: Atherectomy procedure is planned for the target lesion.Target lesion requires treatment with another device, after successful crossing with a study device, other than PTCA devices prior to stent placement.Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin).Previous coronary interventional procedure of any kind within 30 days prior to the procedure.Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as creatine kinase-muscle brain subunits (CK-MB) greater than 3 times the upper limit of normal (ULN).History of allergy to iodinated contrast that cannot be effectively managed medically. ![]() Participants must not meet any of the following exclusion criteria: ![]() A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting the definition of CTO (any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1) and estimated to be in duration of ≥ 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram).Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central Institutional Review Board (IRB)įemale participants of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception.Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG).Participant is eligible and consents to undergo PCI procedure.Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.At least 18 years of age at the time of consent.Participants must meet all of the following inclusion criteria: The Teleflex guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature.The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo chronic total occlusions (CTO).GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo chronic total occlusions (CTO).All study devices are currently 510(k) cleared for non-CTO indications. Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter, and a series of five coronary guidewires (SpectreTM guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, and BanditTM guidewire). The population for this study is participants with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization. This study will enroll up to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample size of at least 135 patients. The study will be conducted in up to 15 investigational sites in the U.S. Why Should I Register and Submit Results?Ī prospective, multicenter, single-arm, intent-to-treat, literature-controlled clinical study.
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