Safety and Efficacy of 6-French Glidesheath Slender in Coronary Angiography and Percutaneous Coronary Intervention Via Distal Transradial Access in Patients With Small Vessels: A Single-Center, Adaptive, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 594
- 试验地点
- 2
- 主要终点
- Distal radial artery occlusion(dRAO)
研究概览
简要总结
Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels.
详细描述
The safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access (dTRA) have been confirmed by a large number of studies, but there are still few studies on its safety and efficacy in patients with small vessels (distal radial artery diameter < 2.0mm). The 6-French Glidesheath Slender, with its smaller outer diameter, should be more suitable for patients with small vessels. To this end, we plan to conduct a single-center, adaptive, randomized controlled trial enrolling 594 patients aged 18-85 years old with distal radial artery diameters <2.0 mm and ≥1.0 mm who are scheduled to undergo coronary angiography and percutaneous coronary intervention via the distal radial artery approach in our center. The study employed a stratification-block randomized design. Stratification was performed based on patient gender, with a block size of 4 within each stratum. Eligible patients were randomly assigned in a 1:1 ratio to either the 6-French Glidesheath Slender group or the 6-French conventional sheath group.
The primary endpoint of the study was distal radial artery occlusion assessed by vascular ultrasound 24 hours postoperatively. Secondary endpoints included puncture success rate, procedure success rate, number of punctures, puncture time, total procedural time, visual analogue scale pain scores during sheath placement, bleeding, hematoma, arteriovenous fistula, finger numbness, and conventional radial artery occlusion at 24 hours postoperatively.
An interim analysis will be conducted when 50% of the total sample size (297 patients) is enrolled, with subsequent sample size adjustments based on preliminary study results.
The results of this study will provide evidence for the safety and efficacy of 6-French Glidesheath Slender for coronary angiography and percutaneous coronary intervention in patients with small vessels via distal transradial access, and provide information for the selection of the best sheath equipment for patients with small vessels.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Because cardiac interventionalists need to know which arterial sheaths to use during the procedure, therefore it is not possible to blind them to this information. But, the investigators responsible for outcome assessment and the personnel responsible for preoperative and postoperative radial artery ultrasound evaluations will be blind of this.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 85 years
- •Palpable pulses in both the distal radial artery and conventional radial artery
- •All patients signed informed consent forms prior to procedure
排除标准
- •Ultrasound assessment of the distal radial artery diameter ≥2.0mm or <1.0mm
- •Height ≥185.0cm
- •Patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, or hemodynamic instability
- •Contraindications for puncture of the distal radial artery
- •Patients with Raynaud's syndrome
- •Patients with coagulation disorders or hematologic diseases
- •Patients currently enrolled in other clinical studies
研究组 & 干预措施
6-French Glidesheath Slender group
Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-French Glidesheath Slender sheath.
干预措施: Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath. (Device)
6-F Conventional sheath group
Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-F Conventional sheath.
干预措施: Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath. (Device)
结局指标
主要结局
Distal radial artery occlusion(dRAO)
时间窗: 24 hours postoperatively.
The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.
次要结局
- Number of punctures(Periprocedural)
- Puncture time(second)(Periprocedural)
- Procedural time(minute)(Periprocedural)
- Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement(Periprocedural)
- Bleeding(24 hours postoperatively)
- Haematoma(24 hours postoperatively)
- Arteriovenous fistula(24 hours postoperatively.)
- Finger numbness(24 hours postoperatively)
- Conventional radial artery occlusion (cRAO)(24 hours postoperatively)
- Puncture success(Periprocedural)
- Procedure success(Periprocedural)
研究者
Cai gaojun, MD
Director, Head of Departments of Cardiology, Clinical Professor.
Wujin People's Hospital