NL-OMON48597已完成不适用
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study - OPTIMIZE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
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
- •1. Subject is >= 18 years old;
- •2. Subject (or subject*s legal representative) understands the
- •study requirements, the treatment procedures and provides
- •written informed consent before any study-specific tests or
- •procedures are performed;
- •3. Japan only: for subjects < 20 years of age, the subject and the
- •subject*s legal representative must provide written informed
- •consent before any study specific tests or procedures are
- •4. Subject is an eligible candidate for PCI;
- •5. Subject has symptomatic coronary artery disease with objective
- •evidence of ischemia or silent ischemia;
- •6. Subject has clinical symptoms or ECG changes consistent with
- •non-ST elevation MI (NSTEMI), is clinically and
- •hemodynamically stable and has cardiac enzymes documented
- •to be decreasing prior to the study procedure (CK-MB is
- •preferred, but if troponin is assessed, enzymes decreasing,
- •stable or elevated up to 20% over the prior assessment are
- •acceptable);
- •7. Subject is an acceptable candidate for CABG;
- •8. Subject agrees to comply with specified follow-up evaluations.;Angiographic Inclusion Criteria (visual estimate):
- •1. Subject has <= 3 de novo target lesions in <= 2 native coronary
- •artery vessels, with <= 2 lesions in a single vessel, each meeting
- •the angiographic criteria and none of the exclusion criteria.
- •2. Target lesion(s) must be located in a native coronary artery
- •with RVD >= 2.25 mm and <= 4.00 mm;
- •3. Target lesion(s) length must be <= 34 mm in length (the intention
- •should be to cover the whole lesion with one (1) stent of
- •adequate length);
- •4. Target lesion(s) must have visually estimated stenosis >= 50%
- •and < 100% with Thrombolysis in Myocardial Infarction (TIMI)
- •flow > 1. For lesions with visually estimated stenosis >= 50%
- •and <= 70%, additional confirmation by ACC/AHA guideline
- •compliant physiologic assessment is required;
- •5. Coronary anatomy is likely to allow delivery of a study device(s)
- •to the target lesion(s).
排除标准
- •1. Subject has clinical symptoms or ECG changes consistent with acute STEMI; Subject may be included if primary PCI for STEMI was successfully completed and subject is clinically and hemodynamically stable with cardiac enzymes documented to be decreasing >= 72 hours prior to the study procedure;
- •2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina;
- •3.- Subject has received an organ transplant or is on a waiting list for an organ transplant;
- •4. Subject is receiving or scheduled to receive chemotherapy 30 days before or after the index procedure;
- •5. Subject requires a planned PCI (including staged procedures) or CABG after the index procedure; CABG or surgical or catheter-based valvular intervention within 12 months of) the index procedure;
- •6. Subject was previously treated at any time with intravascular brachytherapy;
- •7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the study stent systems or protocol-required concomitant medications (e.g. platinum, platinum-chromium alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin);
- •Subject has one of the following (as assessed prior to the index procedure):
- •a. Other serious medical illness (e.g. cancer, congestive heart failure) with estimated life expectancy of <=24 months;
- •b. Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.);
- •c. Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
- •9. Subject is receiving chronic (>=72 hours) anticoagulation therapy (e.g. heparin, coumadin) for indications other than acute coronary syndrome (ACS);
- •10. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
- •11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3;
- •12. Subject has documented significant liver disease including laboratory evidence of hepatitis;
- •13. Subject is on dialysis or has a baseline serum creatinine level > 2.0 mg/dL (177µmol/L);
- •14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
- •15. Subject has a history of a CVA or a TIA within the past 6 months;
- •16. Subject has an active peptic ulcer or active GI bleeding;
- •17. Subject has severe symptomatic heart failure (i.e. NYHA class IV);
- •18. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
- •19. Subject has a known intention to procreate within 12 months after the index procedure (a woman of child bearing potential who is sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure);
- •20. Subject is pregnant or nursing (subject must have a negative pregnancy test within 14 days prior to the index procedure if a woman of childbearing potential);
- •21. Subject is participating in another investigational drug or device study;
- •22. Planned use of cutting balloon, atherectomy or atherectomy orbital, laser or other) any other form of treatment of the target lesion(s) during the index procedure other than plain balloon angioplasty and the randomized stent.;Angiographic Exclusion Criteria (visual estimate): <
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