Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The absolute change in minimal lumen area (MLA)
研究概览
简要总结
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).
详细描述
This is a pilot study that aim to enroll 60 subjects with high bleeding risk.
All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will remain blinded until the final study results are released.
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
- •Coronary artery disease (CAD) patients with high risk of bleeding
排除标准
- •Previous coronary artery bypass graft (CABG) patients
- •Stent implantation in the target vessel
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
- •Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- •Cardiac shock
- •Pregnancy
- •Expected life less than 12 months
结局指标
主要结局
The absolute change in minimal lumen area (MLA)
时间窗: 6 months
The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
次要结局
- Bailout drug-eluting stents (DES) implantation rate(During procedure)
- Plaque burden(immediately after procedure)
- Dissection(immediately after procedure)
- Fractional Flow Reserve (FFR) value(immediately after balloon predilation)
- Minimum lumen area (MLA)(immediately after procedure)
- Minimum lumen diameter (MLD)(immediately after procedure)
- The diameter stenosis of target lesion(6 months)
- The binary restenosis of target lesion(6 months)
- The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis(6 months)
- The late lumen loss of target lesion(6 months)
- Atheroma volume(immediately after procedure)
研究者
Junjie Zhang
Vice Director of Cardiovascular Department
Nanjing First Hospital, Nanjing Medical University