Sapphire 3 CTO Study

A regiszterben nem jelölt feltételek

• Clinical Inclusion Criteria:
• Subject is ≥ 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
• Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
• Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
  • Angiographic Inclusion Criteria
• Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
• A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
• Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
• The Target lesion is intended for stent placement during this index procedure.
  • Clinical Exclusion Criteria:
• Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
• Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
• Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
• Planned or actual target lesion treatment prior to the use of the Study Device with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
• A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
• Cerebrovascular accident (CVA) within the past 6 months.
• Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
• Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).
  • Angiographic Exclusion Criteria
• More than two lesions requiring treatment.
• Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis).
• Coronary artery spasm of the target vessel in the absence of a significant stenosis.
• Target lesion with angiographic presence of probable or definite thrombus of TIMI thrombus grade 3 or 4.
• By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.25 mm in diameter.
• Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel.
• Target vessel with a patent bypass graft from prior coronary bypass surgery.
• Previous stenting (drug-eluting or bare metal) in the target vessel unless all the following conditions are met:
  • It has been at least 9 months since the previous stenting.
  • That target lesion is at least 15 mm away from the previously placed stent. Total occlusions involving an in-stent segment are excluded.
  • The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
• Non-target lesion to be treated during the index procedure meets any of the following criteria:
  • Located within a bypass graft (venous or arterial)
  • Left main location
  • Chronic total occlusion (CTO)
  • Is moderately to severely calcified.
  • Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
  • Treatment not deemed a clinical angiographic success