Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 2
- 主要终点
- Rate of successful hemostasis at 30 minutes after sheath removal
研究概览
简要总结
Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO.
GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths.
The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.
详细描述
Patients fulfilling the enrollment criteria will be randomized 1:1 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery (dTRA). In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis.
For randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. Follow-up ultrasound 7-10 days after the procedure for detection of RAO, distal radial artery occlusion and fistula formation will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Indication for coronary angiography
- •Age>18 years
- •Informed consent
排除标准
- •Non-palpable right radial artery
- •Prior CABG
- •Prior right transaradial intervention within the previous 2 months
- •Hemodynamic instability
- •Anatomical restrictions (fistula orthopaedic problems, etc)
结局指标
主要结局
Rate of successful hemostasis at 30 minutes after sheath removal
时间窗: At 30 minutes after sheath removal
次要结局
- Rate of pseudoaneurysm formation(7-10 days after the coronary angiography)
- Crossover rate to conventional radial access(During the procedure)
- Pain associated with the procedure (visual analog scale, VAS)(During the procedure)
- Rate of hematoma modified EASY class≥II(Up to 24 hours after hemostatic device removal)
- Rate of forearm radial artery occlusion(7-10 days after the coronary angiography)
- Rate of fistula formation(7-10 days after the coronary angiography)
- Rate of distal radial artery occlusion(7-10 days after the coronary angiography)
研究者
Grigorios Tsigkas
Assistant Professor of Cardiology
University Hospital of Patras