A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
研究概览
简要总结
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.
详细描述
The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •Stable Angina or Unstable Angina
- •Single restenotic lesion in a previously stented coronary artery
排除标准
- •Acute Myocardial Infarction within 72h
- •Serum Creatinine>2.0 mg/dL
- •Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
- •Contraindications to contrast media
- •Life expectancy < 2y
- •Target Lesion length > 30mm
- •Target Lesion diameter <= 2.5 mm
- •Target stenosis < 70%
- •Massive Calcifications in the target segment
- •Evidence of intra-coronary thrombus
研究组 & 干预措施
Paclitaxel-eluting Stent
Paclitaxel-eluting Stent Implantation
干预措施: Paclitaxel-eluting Stent (Device)
Paclitaxel-coated Balloon
Paclitaxel-coated Balloon Angioplasty
干预措施: Paclitaxel-coated Balloon (Procedure)
结局指标
主要结局
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
时间窗: 6 months
次要结局
- Major Adverse Cardiac Events(6, 12 months)
- Target Lesion Revascularization(6, 12 months)
- Binary restenosis defined as >50% diameter stenosis by QCA(6 months)