Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Fluoroscopy time
研究概览
简要总结
The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.
详细描述
Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly.
The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnostic angiography of coronary vessels, PCI
排除标准
- •Patients with impaired renal function tests.
- •Lack of informed consent.
- •Severe infection.
- •Previous contrast allergy.
- •Severe intrinsic/iatrogenic caogulopathy INR>
- •Abnormal modified Allen's test.
结局指标
主要结局
Fluoroscopy time
时间窗: 4 years
measure of radiation exposure
Access time
时间窗: 4 years
Access time for the procedures
Procedure time
时间窗: 4 years
time taken to do the full procedure
hospital stay
时间窗: 4 years
time period the patient stayed in the hospital
次要结局
- pseudoaneurysm(4 years)
- Access site failure(4 years)
- hematoma(4 years)
- bleeding(4 years)
研究者
Khalid Changal
Principal Investigator
Sheri Kashmir Institute of Medical Sciences