Randomized Comparison of Radiological Exposure Between Radial and Femoral Technique Assessing Use of Protective Device Dedicated TRIPTable® in Patients With Acute Coronary Syndromes Undergoing Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Radiation dose
研究概览
简要总结
Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access.
The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.
详细描述
This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated TRIPTable ® device.
The TripTable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Unstable angina with an indication for invasive stratification
- •Acute coronary syndrome without ST-segment elevation
- •Acute coronary syndrome with ST-segment elevation
- •Patient informed of the nature of the study and have signed the Informed Consent
- •Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral
排除标准
- •Below 18 years of age
- •Pregnancy
- •Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa,
- •Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3);
- •Uncontrolled hypertension;
- •Cardiogenic shock;
- •Previous coronary artery bypass graft surgery with the use of ≥ 1 graft
- •Patients not candidates for the use of any of the specified vascular access
- •Concomitant severe disease with life expectancy less than 12 months life;
- •Medical, geographical, or social conditions that impede study participation
- •Refusal or inability to understand and sign the informed consent form.
结局指标
主要结局
Radiation dose
时间窗: 1 year
Accumulated radiation dose received by the operator during the interventional cardiology procedures as measured by Thermoluminescent Dosimeters (TLD)
次要结局
- Operator absorbed radiation according total radiation dose(1 year)
- Radiation according measured site(1 year)
- Success of procedure(1 year)
研究者
Igor Bienert
MD
Marilia Medicine School