NL-OMON22538尚未招募不适用
EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries
.A.0 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
- 不适用
- 状态
- 尚未招募
- 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
入选标准
- •Age = 18 years
- •An indication for PCI of a calcified lesion in a native coronary artery
- •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
- •Written informed consent with agreement of follow-up visits.
- •Eligible for PCI with a target vessel reference diameter between 2.5 and 4.0 mm (by visual estimation).
排除标准
- •Severe congestive heart failure, severe heart failure NYHA IV
- •ST-elevation myocardial infarction as indication for PCI
- •Severe renal impairment with a glomerular filtration rate of <30ml/min/1.73m2
- •Lesion related exclusion criteria
- •Stent occlusion / restenosis
- •OCT images not fulfilling inclusion criteria
- •Inability to cross the lesion with an OCT catheter
- •Large side branch (>2.0mm) originating from the target lesion
- •Contraindication for dual antiplatelet therapy.
- •Recent history of major bleeding, hematologic disease and/or platelet count < 100.000 per 1 mm3
- •Planned major surgery within 3 months after the procedure.
- •Participation in another clinical study, interfering with this protocol.
- •The inability to provide written informed consent.
- •Expected life expectancy of less than two years.
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