NL-OMON49291招募中4 期
EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries - EXIT-CALC
OLVG0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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. Age >= 18 years
- •2. An indication for PCI of a calcified lesion in an native coronary artery
- •3. Main OCT criterium is a calcification score of 4 defined as maximum calcium
- •angle of >180 degrees, maximum calcium thickness >0.5mm, and a minimal calcium
- •length of 5mm, as measured at the target lesion
- •4. Written informed consent with agreement of follow-up visits.
- •5. Eligible for PCI with a target vessel reference diameter between 2.5 and 4.0
- •mm (by visual estimation).
排除标准
- •1. Severe congestive heart failure, severe heart failure NYHA IV
- •2. ST-elevation myocardial infarction as indication for PCI
- •3. Severe renal impairment with a glomerular filtration rate of <30ml/min/1.73m2
- •4. Lesion related exclusion criteria
- •5. Stent occlusion / restenosis
- •6. OCT images not fulfilling inclusion criteria
- •7. Inability to cross the lesion with an OCT catheter
- •8. Large side branch (>2.0mm) originating from the target lesion
- •9. Contraindication for dual antiplatelet therapy.
- •10. Recent history of major bleeding, hematologic disease and/or platelet count
- •< 100.000 per 1 mm3
- •11. Planned major surgery within 3 months after the procedure.
- •12. Participation in another clinical study, interfering with this protocol.
- •13. The inability to provide written informed consent.
- •14. Expected life expectancy of less than two years.
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