Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Late luemn loss (LLL)
研究概览
简要总结
The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.
详细描述
The study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara, USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation, rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES implantation.
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
- Double (Participant, 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
- •Age ≥18 years
- •Informed, written consent by the patient
- •Ability to comply fully with the study protocol
- •Negative pregnancy test (and effective contraception) in women with childbearing potential
- •Angiographic inclusion criteria:
- •Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI
- •Heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography
- •Reference vessel diameter (RVD) ≥2.5 mm with lesion length <32 mm
- •TIMI flow 3 of the target vessel at baseline
- •No visible thrombus at target lesion site
排除标准
- •Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support
- •Active malignancy or other comorbidities with a life expectancy of 12 months
- •Limited the possibility of control coronaro angiography (e.g., advanced renal failure)
- •Known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy
- •Current problems with substance abuse (e.g., alcohol or drugs)
- •Subject is participating in another investigational drug or device clinical study
结局指标
主要结局
Late luemn loss (LLL)
时间窗: 1 year
difference between post-procedure MLD and 12-month MLD
Minimal lumen diamether (MLD)
时间窗: 1 year
minimal diamether of treated lesion measured by quantitative coronary angiography
次要结局
- Binary in-stent restenosis(1 year)
- Major adverse cardiac events (MACE)(1 year)