Randomized Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization
研究概览
简要总结
Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques.
In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B.
In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary angiography showing chronic coronary total
排除标准
- •Acute coronary syndrome within 3 months.
- •Patients with previous coronary artery bypass graft (CABG).
- •Patients with known renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
结局指标
主要结局
outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization
时间窗: 6 months
the study will assess the composite of cardiac death, myocardial infarction, or target vessel revascularization, rehospitalization, coronary artery bypass surgery and stroke within both groups
次要结局
未报告次要终点
研究者
Mohamed Osman Abdelhamead
Assistant lecturer
Assiut University