Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of stent expansion by optical coherence tomography
研究概览
简要总结
Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
详细描述
Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.
However there is no direct randomized comparison between these three tools in this scenario.
The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.
The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with <20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .
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
- •Patients >18 years.
- •Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm.
- •Moderate to severe angiographic calcification
- •Stable coronary artery disease or NSTEMI.
- •Native coronary vessel or bypass graft.
排除标准
- •Knwon allergies to aspirin or P2y12 inhibitors.
- •Cardiogenic shock at the time of PCI.
- •Treated lesion in a bifurcation with side branch diameter > 2mm.
- •Absence of informed consent.
- •Impossibility for 1year follow up.
结局指标
主要结局
Percentage of stent expansion by optical coherence tomography
时间窗: At the end of percutaneous coronary intervention
We will analyze with optical coherence tomography the percentage of stent expansion (defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas).
次要结局
- Strategy success rate(At the end of percutaneous coronary intervention)
研究者
Alfonso Jurado, MD, PhD
Principal Investigator
Hospital Universitario La Paz