NL-OMON35790已完成4 期
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With single de novo Coronary Artery Lesions - II - BIOFLOW-II
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biotronik
- 入组人数
- 28
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Subject has provided a written informed consent
- •2.Subject is * 18 years and * 80 years old
- •3.Single de novo lesion with * 50% and <100% stenosis in up to 2 coronary arteries
- •4.Subject, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent
- •5.The target lesion length is * 26 mm (assessed either visually or by online Quantitative Coronary Angiography (QCA)) and can be covered by one study stent
- •6.The target reference vessel diameter is * 2.25 mm and * 4.0 mm (assessed either visually or by online QCA)
- •7.Target vessel(s) TIMI flow * 2
- •8.Subject is an acceptable candidate for CABG
- •9.Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
- •10. Eligible for Dual Anti Platelet Therapy (DAPT) treatment with Acetylsalicylic Acid (ASA) plus either, Clopidogrel, Prasugrel, Ticlopidine or Ticagrelor
排除标准
- •1.Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
- •2.Evidence of myocardial infarction within 72 hours prior to index procedure
- •3.Subjects with CK, CKMB(optional) and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure
- •4.Unprotected left main coronary artery disease (stenosis >50%)
- •5.Three-vessel coronary artery disease at time of procedure
- •6.Thrombus in target vessel
- •7.Planned interventional treatment of any non-target vessel within 30 days post-procedure
- •8.Planned intervention of the target vessel after the index procedure
- •9.Ostial target lesion (within 5.0 mm of vessel origin)
- •10.Target lesion involves a side branch > 2.0 mm in diameter
- •11.Documented left ventricular ejection fraction (LVEF) * 30%
- •12.Heavily calcified lesion
- •13.Target lesion is located in or supplied by an arterial or venous bypass graft
- •14.The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)
- •15.Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus,Tacrolimus); CoCr, PLLA, Silicon Carbide
- •16.Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- •17.Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- •18.Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
- •19.Life expectancy less than 1 year
- •20.Planned surgery or dental surgical procedure within 6 months after index procedure
- •21.In the investigators opinion subject will not be able to comply with the follow-up requirements
- •22.Subject is currently participating in another study and has not reached the primary endpoint
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