NL-OMON32730已完成4 期
COBRA II Study (Use of the Cobra Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease) - COBRA II Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •General Inclusion Criteria:
- •1. The subject is >= 18 years old;
- •2. Subject is eligible for percutaneous coronary intervention (PCI), stent placement, and emergent coronary artery bypass graft (CABG) surgery;
- •3. Subject has clinical evidence of ischemic heart disease, stable or unstable angina or silent ischemia;
- •4. The subject has a documented left ventricular ejection fraction (LVEF) >= 30%;
- •5. The subject or legal representative has been informed of the clinical study and the required follow-up procedures and must provide written informed consent using a form that is reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) for the clinical site;
- •6. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before treatment;
- •7. Subject must agree to comply with the required follow-up procedures (including
- •antiplatelet regimen) to the best of their ability, be geographically available for all study follow-up procedures and visits and not have a known medical condition that precludes completion of the required follow-up visits.;Angiographic Inclusion Criteria:
- •8. The lesion is either de novo or restenotic (previously unstented) in nature, located in a native coronary artery AND is >= 50% and < 100% stenosed by visual estimate or on-line QCA;
- •9. The target vessel reference diameter >= 2.5mm and <= 4mm by visual estimate and is appropriate for treatment with available stent diameters of 2.5 mm, to 4.0 mm;
- •10. The lesion length is able to accommodate placement of a single stent;
- •11. The target lesion is a minimum of 15 mm from any previously placed stent;
- •12. The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow >= 2.
排除标准
- •General Exclusion Criteria:
- •1. The subject has a known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, ticlopidine and clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated;
- •2. A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a WBC < 3,000
- •3. A creatinine level > 2.5 mg/dL within 7 days prior to the index procedure;
- •4. Evidence of an acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q wave (QWMI) or any elevation of creatine kinase myocardial-band (CKMB) isoenzyme elevated above the Institution's upper limit of normal;
- •5. Any previous PCI (with or without stent) of the target vessel within 30 days prior to the index procedure;
- •6. Previous stent placement anywhere in the target lesion;
- •7. Previous drug eluting stent (DES) deployment anywhere in the target vessel;
- •8. The subject requires staged procedure of any non-target vessel within 30 days postprocedure;
- •9. The subject requires staged procedure of the target vessel within 9 months postprocedure;
- •10. The target lesion requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.);
- •11. History of a stroke or transient ischemic attack (TIA) within the previous 6 months;
- •12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the previous 6 months;
- •13. History of bleeding diathesis or coagulopathy or will refuse blood transfusions;
- •14. A known concurrent medical condition resulting in a life expectancy of less than 12 months;
- •15. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy;
- •16. The subject is currently participating in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial; or interferes with the current trial endpoints; or the subject has previously been enrolled in the study;
- •17. The subject has a known medical condition that will cause them to be non-compliant with the study protocol or confound the data interpretation.;Angiographic Exclusion Criteria:
- •18. The target vessel has evidence of thrombus or other lesions having a > 60% stenosis by visual estimate or on-line QCA;
- •19. Target vessel exhibiting multiple lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA;
- •20. The target vessel has evidence (visual or QCA) of excessive tortuosity (two or more 90° bends prior to the target lesion) or is severely calcified;
- •21. The target lesion is in an unprotected left main, involves a side branch vessel having a diameter of > 2.0 mm or is at the aorto-ostial location.
研究者
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