NCT01430377Unknown4 期
Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
Medica Cor Heart Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time for rewiring SB
研究概览
简要总结
The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Subject at least 18 years of age.
- •Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- •Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
- •Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
排除标准
- •ST-segment elevation myocardial infarction (STEMI)
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Subjects who refuse to give informed consent.
- •Subjects with left ventricle ejection fraction <30%
- •Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
- •Contraindications for 12 months double antiplatelet therapy
结局指标
主要结局
Time for rewiring SB
时间窗: 24h
次要结局
- MACE(12 months)
- Periprocedural myonecrosis(24 h)
研究者
Dobrin Vassilev MD, PhD
Dobrin Vassilev MD, PhD
Medica Cor Heart Hospital
研究点 (2)
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