NL-OMON51361尚未招募不适用
Calcium Reduction by Orbital Atherectomy in Western Europe: the CROWN study - CROW
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
暂无简介。
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. De novo significant native coronary artery lesion.
- •2. The target lesion must have evidence of severe calcification:
- •a. Presence of radiopacities noted without cardiac motion prior to contrast
- •injection involving both sides of the arterial wall with calcification length
- •of at least 15 mm and extend partially into the target lesion.
- •b. Presence of >=270° of calcium or lumen protruding calcified nodule(s) at >1
- •cross section assessed by OCT.
- •3. The target vessel reference diameter >= 2.5 mm and <= 4.0 mm and lesion must
- •not exceed 40 mm in length.
- •4. Age > 18 years or minimum age as required by local regulations
排除标准
- •1. Left main disease
- •2. Prior stenting of the target vessel.
- •3. Target lesion has thrombus or dissection.
- •4. Known LVEF <=25%.
- •5. Diagnosed with chronic renal failure (GFR<30ml/min)
- •6. Confirmed pregnancy.
- •7. Life expectancy <12months.
- •8. Age<18y.
- •9. Coronary anatomy that prevent delivery of OCT catheter
- •10. Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium
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