跳至主要内容
临床试验/NCT07060820
NCT07060820招募中不适用

Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures

Mersin Medicalpark Hastanesi2 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2025年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
380
试验地点
2
主要终点
Incidence of Radial Artery Spasm during Transradial Coronary Angiography

研究概览

简要总结

This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Patients undergoing coronary angiography via radial access will be randomized into two groups based on the puncture site distance: 0-20 mm and >21 mm from the styloid process. The procedure will be performed by experienced interventional cardiologists using standard techniques and medications. The primary goal is to determine if a specific puncture site reduces the incidence of RAS, which is a common complication during transradial procedures. The study will also record procedural details and monitor for other complications to identify the optimal puncture site for reducing RAS and improving patient comfort.

详细描述

The transradial approach (TRA) is the standard vascular access route for diagnostic coronary angiography and percutaneous coronary interventions, in accordance with contemporary guidelines, due to lower bleeding risk, improved patient comfort, and facilitation of early mobilization compared with femoral access. Despite these advantages, radial artery spasm (RAS) remains a common and clinically relevant complication during transradial procedures, often associated with procedural difficulty, the need for access site crossover, and patient discomfort.

RAS is characterised by sudden, transient contraction of the radial artery during sheath insertion or catheter manipulation, which may result in difficulty in catheter advancement, and, in rare cases, procedural failure or catheter entrapment. Several clinical and procedural factors have been identified as being associated with the development of RAS, including female sex, smaller arterial diameter, use of larger sheaths, inadequate sedation, and limited operator experience. Currently radial access is recommended near the styloid process but there is limited data on the effects of different puncture distances from the styloid process on the development of RAS. We examined the impact of different radial artery puncture distances from the styloid process, on the development of radial artery spasm and access-site-related complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older. Patients scheduled for coronary angiography via transradial access. Patients with a palpable radial artery pulse. Patients with a normal Allen test.

排除标准

  • Abnormal Allen test results. Absence of palpable radial artery pulse. History of prior transradial coronary angiography with hemodynamic instability. Patients with severe comorbid conditions precluding safe participation in the study.

结局指标

主要结局

Incidence of Radial Artery Spasm during Transradial Coronary Angiography

时间窗: During the procedure

Incidence of Radial Artery Spasm (RAS) during transradial coronary angiography

时间窗: During the procedure

Radial artery spasm will be defined by the presence of at least two of the following: persistent forearm pain, pain during catheter manipulation, difficult catheter manipulation due to arterial spasm, pain during sheath removal, and significant resistance during sheath removal.

次要结局

  • Incidence of access site complications(Within 5 days post-procedure)

研究者

发起方
Mersin Medicalpark Hastanesi
申办方类型
Other
责任方
Sponsor

研究点 (2)

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