Drug coated balloons in treatment of de novo coronary lesions: A prospective multicenter registry (Kerala DCB Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 28
- 主要终点
- To study clinical
研究概览
简要总结
To study clinical, procedural characteristics of patients undergoing PCI with DCB in native vessel disease. Lesion subsets like large vessel (>3.0 mm), long lesions, bifurcations, chronic total occlusions (CTO), proximal vessel disease receiving DCB treatment are of special interest. Clinical subsets like ST elevations myocardial infarction (STEMI) , Non ST elevations acute coronary syndrome are to be studied.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are more than 18 years undergoing PCI to native vessel with DCB and Vessels with reference diameter 2.0 – 4mm.
排除标准
- •Saphenous vein graft & other bypass graft lesions Left main Severe tourtous lesions Heavily calcified lesions Vessel diameter morethan 4.0mm Expected life expectancy less than 1 year Severe liver disease lessthan Child Pugh B Severe CKD eGFR morethan 30ml/min/m2 Advanced malignancy Known contraindication for paclitaxel or sirolimus.
结局指标
主要结局
To study clinical
时间窗: In hospital | 30 days | 3 days | 6 days | 12 months
procedural characteristics of patients
时间窗: In hospital | 30 days | 3 days | 6 days | 12 months
undergoing PCI with DCB in native vessel disease
时间窗: In hospital | 30 days | 3 days | 6 days | 12 months
Lesion sub sets like large vessel morethan 3.0mm
时间窗: In hospital | 30 days | 3 days | 6 days | 12 months
次要结局
- Long lesions-bifurcations-Chronic total occlusions CTO, proximal(vessel disease receiving DCB treatment are of special interest-Clinical subsets)
研究者
DR JABIR ABDULLAKUTTY
LISIE HOSPITAL KOCHI KERALA