KCT0007408尚未招募未知
Tailored versus Conventional Antiplatelet Strategy intended After Optimized Drug Eluting Stent
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 3,944
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Men or women =18 years
- •2) Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
- •3) Significant de novo coronary artery lesions suitable for DES implantation
- •4) Patients who underwent optimized stent implantation either by IVUS or OCT
- •5) The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
排除标准
- •1) Angiographic exclusion criteria: any of the followings
- •1. Bypass graft lesions
- •2. Lesions in which impaired delivery of imaging catheters is expected:
- •- Extreme angulation (=90°) proximal to or within the target lesion.
- •- Excessive tortuosity (= two 45° angles) proximal to or within the target lesion.
- •- Heavy calcification proximal to or within the target lesion.
- •2) In-stent restenosis
- •3) Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- •4) Persistent thrombocytopenia (platelet count <80,000/l)
- •5) Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
- •6) A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
- •7) Patients requiring long-term oral anticoagulants or cilostazol
- •8) Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
- •9) A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- •10) Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •11)History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
- •12)Life expectancy < 1 years for any non-cardiac or cardiac causes
- •13)Cardiogenic shock at the index admission
- •14)Patient’s pregnant or breast-feeding
- •15)Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
- •16)Unwillingness or inability to comply with the procedures described in this protocol.
研究者
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