Intravascular Lithotripsy and Rotational Atherectomy in Treatment of Severely Calcified Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Strategy success
研究概览
简要总结
This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.
详细描述
Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .
Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .
Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.
Intravascular imaging as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are good tools to assess calcium burden, distribution and thickness. Among the two imaging techniques, OCT was found to be more accurate than IVUS in defining calcium burden, calcium area , thickness and calcium length.
Rotational atherectomy (RA) as a method of severely calcified lesions modification before Drug-Eluting-Stent (DES) implantation has shown good outcomes in recent studies. However, its efficacy is reduced in presence of deep calcification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 aged >18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
- •Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch >180º in at least one cross section , calcium length >5mm, calcium thickness >0.5 mm (2, 6).
- •Vessel diameter ≥2.5mm and ≤4.0mm .
- •Heavily calcified lesion length less than 40mm.
- •All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention
排除标准
- •Severe coronary calcification with lesion uncrossable from a balloon.
- •PCIs in the setting of STEMI or NSTEMI with persistent complains.
- •Patients in cardiogenic shock.
- •Heart failure New York Heart Association (NYHA) class IV.
结局指标
主要结局
Strategy success
时间窗: Up to one day
less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.
次要结局
- Major Adverse Cardiac Events(after one year)
研究者
Mohamed Aboelkasem Ali Mousa
Assistant lecturer
Assiut University