JPRN-jRCT1092220172已完成3 期
Efficacy and safety of CP stent implantation for pulmonary stenosis associated with congenital heart diseases
Hideshi Tomita0 个研究点目标入组 25 人开始时间: 2014年3月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
Efficacy and safety of CP stent implantation using BIB and Z-MED II balloon was demonstrated by our clinical trial for pulmonary stenosis associated with congenital heart diseases.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 40age old（—）
- 性别
- All
入选标准
- •Those who have one or two lesions of post-operative pulmonary stenosis including those of post-fenestrated Fontan operation, and have a history of ineffective PTA for the lesion within one year of enrollment, or PTA for the lesion will not be effective. Candidates must meet following 1) or 2) criteria.
- •1)After Bi-ventricle repair; Either one of following (1)-(3)
- •(1)Elevation of RVp associated with PS Systolic RVp/ Systolic ascending AOp > 0.7
- •(2)Systolic pressure gradient through the stenosis>20 mmHg
- •(3)Stenosis ratio(1-MLD/ Ref vessel diameter)> 0.5
- •2)After Uni-ventricular repair; Either one of following(1)-(3)
- •(1)Mean pressure gradient through the stenosis>3 mmHg
- •(2)Stenosis ratio(1-MLD/ Ref vessel diameter)>0.5
- •(3)Morphologically definite stenosis complicated by SaO2<85%
排除标准
- •(1)Previously implanted stent in the target lesion
- •(2)Contraindication for anti-coagulation or anti-platelet therapy
- •(3)Hemorrhagic diathesis or Hyper-coagulation state
- •(4)Active infection including endocarditis
- •(5)Serious Liver and/or Kidney damage
- •(6)Enrolled in the other clinical trials
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