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临床试验/NCT06688747
NCT06688747尚未招募不适用

Distal Versus Traditional Radial Access for Coronary Angiography and Intervention

Assiut University0 个研究点目标入组 230 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
230
主要终点
To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge

研究概览

简要总结

The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention

详细描述

Trans radial access (TRA) has become the standard vascular access for coronary angiography and percutaneous coronary intervention (PCI) and is currently endorsed with a class IA recommendation in the latest European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization, irrespective of clinical presentation Several clinical and procedural characteristics have been linked to the occurrence of RAO, and best practices recommendations for the prevention of RAO include reduction of the sheath/catheter size, adequate procedural anticoagulation, non-occlusive hemostasis (4) and a minimal pressure strategy with short (≤ 120 min) hemostasis time. The use of the distal radial artery with arterial access in the anatomical snuffbox or on the dorsum of the hand, has recently emerged as a promising alternative access route to further reduce the risk of RAO (5) The distal radial artery may be punctured proximally to the tendon of the extensor pollicis longus muscle in the anatomical snuffbox or distally to it in the dorsum of the hand.(6) the distal radial artery lies in the subcutaneous space superficial to the fascial compartments of the hand, thus favoring a faster, and safer hemostasis as compared to conventional TRA(7) The study will enroll 228 patients who will undergo a diagnostic coronary angiography and/or a PCI using a 6 Fr Sheath as the standard access sheath will be divided into two groups DRA versus TRA (114 cases in each group) The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure The secondary endpoints as successful sheath insertion, access site cross-over, total procedure time, sheath insertion time, puncture site bleeding overall bleeding, vascular access-site complication and radial artery spasm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Signed informed consent form
  • Indication to diagnostic coronary angiography or PCI
  • Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath

排除标准

  • Chronic hemodialysis
  • Treatment of a coronary chronic total occlusion (CTO) lesion
  • Patients who underwent CA or PCI with radial access before

结局指标

主要结局

To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge

时间窗: One year

The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure and follow up after 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Talaat Bakr

Cardiology specialist

Assiut University

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