Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- stent expansion index
研究概览
简要总结
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) & intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
详细描述
Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.
As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.
Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.
In summary, this randomized trial aimed to evaluate the stent expansion through intravascular imaging among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 80 years
- •Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
- •Have an indication for drug-eluting stent (DES) implantation
- •Denovo coronary artery calcified lesions
- •Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and < 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
- •Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
- •Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
- •Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of < 30% under maximal inflation pressure.
- •Provision of written informed consent
排除标准
- •Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
- •Presented as severe contrast agent allergy
- •Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
- •Presented as active phase of autoimmune disease
- •Calcified nodules or eccentric calcification lesions
- •Failure to reach the target lesion with guidewires or catheters
- •Complex coronary bifurcation lesions
- •Target vessel thrombosis or aneurysm within 10 mm of the target lesion
研究组 & 干预措施
Super high-pressure balloon
Patients underwent intravascular imaging -guided PCI were treated with super high-pressure balloon for lesion preparation.
干预措施: super high-pressure balloon (Device)
Intravascular lithotripsy (IVL)
Patients underwent intravascular imaging -guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation.
干预措施: intravascular lithotripsy (IVL) (Device)
结局指标
主要结局
stent expansion index
时间窗: Intraprocedural
The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).
次要结局
- 30-days major adverse cardiac event (MACE)(30 days)
研究者
Ye-fei
chief physician
Nanjing First Hospital, Nanjing Medical University