NL-OMON38851已完成4 期
PREdilatation by high-pressure NC balloon catheter for better vessel preparation - PRE-NC study
SIS MEDICAL AG0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •Patient must be >18 years of age
- •- Patient is willing to comply with specified follow-up evaluations;
- •- Patient has stable or unstable angina diagnosed
- •- De novo lesion
- •- Vessel diameter between 2.25 and 4.0 mm
- •- Lesion qualified for predilatation or for direct stenting strategy are allowed
- •- Patient has no more than two-vessel disease and no more than one lesion per vessel
- •- Patient with target lesion localized in bifurcations can be enrolled to the study
- •- The subject has been informed of the nature of the study and has been provided and signed written informed consent approved by the appropriate Ethics Committee (EC)
排除标准
- •- Visible thrombus in angiography
- •- Total occlusion
- •- More than one lesion in target vessel
- •- Diagnosis of myocardial infarction
- •- Pregnant or nursing patient or planned pregnancy in the period up to 1 year following index procedure
- •- Patient with contraindications for 12 months of dual antiplatelet therapy
- •- Patient with contraindications for DES or BVS implantation
研究者
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