GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of distal radial artery occlusion
研究概览
简要总结
Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.
详细描述
Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio > 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath Slender® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Palpable distal radial and conventional radial artery
排除标准
- •Age ≥ 90years
- •Height≥ 185cm
- •ST-segment elevation myocardial infarction or Cardiogenic shock
- •Contraindications to puncture at the puncture site
- •Diameter of DRA less than 1.5mm or RAO
研究组 & 干预措施
GlideSheath Slender®
Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery
干预措施: GlideSheath Slender® and conventional arterial sheath (Device)
Conventional Sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery
干预措施: Conventional arterial sheath (Device)
结局指标
主要结局
Rate of distal radial artery occlusion
时间窗: 24 hours after the coronary angiography or intervention
The rate of distal radial artery occlusion is evaluated by ultrasound
次要结局
- Pain during the placement of the sheath(24 hours after the coronary angiography or intervention)
- Radial artery dissection(24 hours after the coronary angiography or intervention)
- Rate of radial artery occlusion(24 hours after the coronary angiography or intervention)
- Haematoma(24 hours after the coronary angiography or intervention)
- Time of hemostasis(24 hours after the coronary angiography or intervention)