Comparison of Distal and Conventional Transradial Access for Coronary Catheterization: A Multicenter, Quasi-Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Radial artery occlusion (RAO) assessed by duplex ultrasonography
研究概览
简要总结
Background: Radial artery occlusion (RAO) is a recognized complication of transradial coronary access, with reported incidence rates ranging from 5% to 30%. Distal radial access (DRA), performed at the anatomical snuffbox, has emerged as a promising alternative that may better preserve radial artery patency by maintaining antegrade perfusion through the palmar arch during hemostasis.
Objective: To compare distal radial access with conventional transradial access in terms of radial artery patency and access-site outcomes in a real-world all-comers population undergoing coronary angiography or percutaneous coronary intervention.
Methods: This prospective, multicenter, open-label, quasi-randomized comparative study enrolled 350 patients across three community-based hospitals in Palestine and Jordan between 2024 and 2026. Patients were allocated in a 1:1 ratio to DRA (n=183) or conventional transradial access (n=167) using an alternating sequence. The primary endpoint was radial artery patency assessed by blinded duplex ultrasonography at 24 hours and at 1 to 6 months. Secondary endpoints included access-site pain, bruising, numbness, and crossover to an alternative access site. The 24-hour outcome was analyzed by intention-to-treat and long-term outcomes by per-protocol analysis. Adjusted analyses used Firth penalized logistic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The ultrasound operator is blinded to the group of the patient.
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
- •Age ≥ 18 years
- •Undergoing diagnostic coronary angiography or percutaneous coronary intervention via an intended radial approach
- •Palpable radial pulse at the intended puncture site
- •Able to provide written or verbal informed consent
- •No contraindication to radial artery access at the intended site, as determined by the treating operator
排除标准
- •Age < 18 years
- •Inability to provide informed consent
- •Absent or non-palpable radial pulse at the intended access site
- •Active pregnancy
- •Medical condition likely to cause non-compliance with the study protocol or confound data interpretation
研究组 & 干预措施
Distal Radial Artery Access Group
干预措施: Distal Radial Artery Access (Procedure)
Conventional Transradial Access Group
干预措施: Conventional Transradial Artery Access (Procedure)
结局指标
主要结局
Radial artery occlusion (RAO) assessed by duplex ultrasonography
时间窗: 24 hours and 1-6 months post procedure
Radial artery occlusion defined as absence of antegrade flow on duplex ultrasonography, assessed within 24 hours and at 1-6 months after the procedure.
次要结局
- Access-Site Pain(24 hours and 1-6 months post-procedure.)
- Crossover to Alternative Access Site(At the time of procedure)
- Access-Site Numbness(24 hours and 1-6 months post-procedure)
- Access-Site Bruising(24 hours and 1-6 months post-procedure)