A Clinical Study of the High-Pressure Cutting Balloon for Interventional Treatment of Calcified Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation
研究概览
简要总结
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
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
- None
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
- •Age ≥18 years;
- •Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
- •Moderate-to-severe calcified lesions on coronary angiography;
- •Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
- •Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
- •In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
- •Provision of written informed consent.
排除标准
- •Life expectancy <1 year;
- •Cardiogenic shock or hemodynamic instability;
- •Left main coronary artery disease;
- •Chronic total occlusion;
- •Bifurcation lesions planned for a "two-stent strategy";
- •Active bleeding;
- •Known history of allergy to contrast media or metals;
- •Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
- •New-onset stroke/transient ischemic attack within 6 months;
- •Pregnant or lactating women;
- •Left ventricular ejection fraction <25%, or NYHA functional class IV, or Killip class ≥2;
- •Non-target vessel revascularization within 30 days before randomization with complications.
研究组 & 干预措施
Test group
In the test group, the lesion is prepared using a high-pressure cutting balloon prior to DES implantation.
干预措施: High pressure cutting balloon (Device)
Control group
In the control group, the lesion is prepared using a non-cutting balloon prior to DES implantation.
干预措施: Non-cutting balloon (Device)
结局指标
主要结局
Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation
时间窗: procedure day (0 day)
IVUS-measured results obtained after stent implantation and prior to balloon post-dilation
次要结局
- Procedural success(procedure day (0 day))
- Strategy success(procedure day (0 day))
- Major adverse cardiac events (MACE)(the hospitalization period and 30-day after procedure)