CTRI/2017/08/009322招募中Unknown
Post Market Surveillance (PMS)Registry of Yukon Choice PC ELITE OR PLUS Coronary Stent System for Percutaneous Coronary Intervention in all comers Indian Population
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 17
- 主要终点
- MI ( Q wave and non-Q wave)
研究概览
简要总结
›To evaluate the safety and effectiveness of the Yukon Choice PC- ELITE OR PLUS Coronary Stent System in the treatment of de novo lesions in native coronary arteries with quality standard temperature control packaging which is powered by a monitoring device.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient ≥ 18 years old.
- •Patient was treated for percutaneous coronary(PCI).
- •Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- •Candidate was operated for coronary artery bypass graft (CABG) .
- •Stable angina pectoris (Canadian Cardiovascular Society – CCS-Class 1, 2, 3 or 4)or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ECG-TT, SPECT, Stress echocardiography or Cardiac CT).
- •Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study). Angiographic Inclusion Criteria
- •Patient was treated for elective stenting of 1 or 2 stenotic lesions in a native coronary artery.
- •Reference vessel ≥ 2.0 mm and ≤ 4.0 mm in diameter by visual estimation.
- •Target lesion ≤ 40 mm in length by visual estimation (the intention should be to cover the whole lesion with maximum 2 stents of adequate length).
- •Protected left main lesion with >50% stenosis.
- •Target lesion stenosis ≥ 70% and < 100% by visual estimation.
- •Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).
排除标准
- •Patients enrolled in any other drug or investigational device or in another stent trial prior 2 years, planned elective surgery or percutaneous intervention within the subsequent 3 months, staged procedure within 9 months post procedure.
- •Patient requiring treatment with a device other than PTCA prior to stent placement.
- •Target lesion exhibiting an intraluminal thrombus at any time.
- •Lesion location that is within 5 mm of the origin of the left anterior descending or circumflex or target lesion is in a bypass graft.
- •Any co-morbid conditions impacting the scientific integrity of the trial, such as patients ability to participate in the trial or to comply with the follow-up requirements, life expectancy of less than 12 months.
- •Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
- •Patients with diagnosis of MI within 48 hours or suspected acute MI at time of enrollment.
- •History of cerebrovascular accident or transient ischemic attack in the last 6 months.
- •Leukopenia, Neutropenia ,Thrombocytopenia, active peptic ulcer or active GI bleeding.
- •History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, stainless steel or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Serum creatinine level >2.0 mg/dl within 7 days prior to index procedure.
- •Unprotected left main coronary artery disease.
- •Target vessel with any lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion.
结局指标
主要结局
MI ( Q wave and non-Q wave)
时间窗: 30, 180, 360 days
Major Adverse Cardiac Events (MACE)
时间窗: 30, 180, 360 days
Cardiac death
时间窗: 30, 180, 360 days
Emergent bypass surgery
时间窗: 30, 180, 360 days
Clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 360 days.
时间窗: 30, 180, 360 days
次要结局
- All death(Cardiac death)
研究者
研究点 (17)
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