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The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
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Inclusion criteria
Angiographic Inclusion Criteria:
Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤4.5 mm.
Target lesion length must measure (by visual estimate) as follows:
Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
Target lesion must be successfully pre-dilated.
Exclusion criteria
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI).
Subject with unstable angina or recent MI (clinically diagnosed within 3 days) must have creatine kinase (CK)/ creatine kinase-myoglobin band(CK-MB) or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
If CK Total >2× ULN, CK-MB must be drawn and the subject is excluded if CK-MB is abnormal.
If CK/CK-MB results are not available at the time of procedure, the subject is excluded if troponin >1× ULN and the subject has at least one of the following:
Subject is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome.
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
Subject has a white blood cell (WBC) count <3,000 cells/mm3.
Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
Subject is on dialysis or has known renal insufficiency (e.g. serum creatinine level >2.0 mg/dL).
Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions.
Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol.
Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure.
Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, or atherectomy) at any time prior to the index procedure.
Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 1 day prior to the index procedure.
Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion.
Angiographic Exclusion Criteria:
Target lesion meets any of the following criteria:
Non-target lesion to be treated during the index procedure meets any of the following criteria:
Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
Subject has protected left main coronary artery disease and a target lesion in the LAD or LCX.
Subject has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required.
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328 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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