Observational Study of Radial Artery Patency Following Catheterization With a 7F Sheath
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Normal reverse Allen test
研究概览
简要总结
Radial artery occlusion may occur after performance of coronary catheterization via the radial artery (transradial approach). In some cases it may be desirable to insert large (7F) catheters via the radial artery, however the impact of increased catheter size on subsequent radial artery patency is unclear. We hypothesize that radial artery occlusion following 7F catheterization is rare and occurs in < 5% of the cases.
详细描述
Background:
Coronary catheterization is a commonly performed diagnostic and therapeutic procedure. The procedure is most commonly performed via the transfemoral approach (via the femoral artery). Recently the transradial approach (via the radial artery) has been gaining popularity since it is associated with decreased risk of bleeding and facilitates patient mobilization following the procedure (1-3). During the catheterization procedure a sheath (tube) is inserted into the access artery so as to enable insertion of catheters and devices into the body. Vascular sheaths may have different internal diameters, which are measured in French (F) units. Commonly used sheath sizes for coronary catheterization are 5F and 6F, however use of larger 7F sheaths is beneficial when more complex procedures are performed such as insertion of two coronary stents. Use of a 7F sheath creates a slightly larger orifice within the blood vessel wall and may potentially increase the risk of damage to the vessel wall and hemorrhage.
The palm of the hand normally receives dual blood supply via the radial and ulnar arteries. Prior to performing transradial catheterization the ability of the ulnar artery to supply blood to the whole palm is confirmed by performing an Allen Test, in order to avoid palmar ischemia if the radial artery becomes occluded following the procedure. Radial artery occlusion in the presence of a normal pre-procedural Allen Test is almost universally asymptomatic, however it may preclude future use of the radial artery for vascular access or as a coronary graft if bypass surgery is performed. The frequency of radial artery occlusion following transradial catheterization ranges from 5% to 15% in different reports (4), depending on many factors such patient selection, degree of anticoagulation during the procedure and the time interval between performance of the procedure and studying the radial artery patency. Use of larger sheaths has also been reported as a risk factor for radial artery occlusion (5), however the true incidence of this complication is unclear. It is desirable to discover the true rate of radial artery occlusion following catheterization with a 7F sheath, since such knowledge may assist physicians in planning the optimal catheterization strategy.
Aims:
The aim of the study will be to examine the occurrence of radial artery occlusion following transradial catheterization with a 7F sheath.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Previous transradial catheterization with a 7F vascular sheath
排除标准
- •Inability to give informed consent
结局指标
主要结局
Normal reverse Allen test
时间窗: Within 2 years of the initial procedure
Radial artery patency will be studied with the reverse Allen test. This test is performed by simultaneously occluding both the radial and ulnar arteries until no pulse signal is detected with a pulse oximeter placed on the index finger. The pressure on the radial artery is then released and reappearance of the pulse signal on the oximeter is documented-signifying antegrade flow in the radial artery. This test is not associated with any reported complications or morbidity.
次要结局
- Antegrade flow in the radial artery by ultrasound(Within 2 years of the initial procedure)