跳至主要内容
临床试验/NCT06835829
NCT06835829进行中(未招募)不适用

Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial

Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS6 个研究点 分布在 2 个国家目标入组 480 人开始时间: 2025年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
480
试验地点
6
主要终点
Hemostasis duration.

研究概览

简要总结

Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever.

However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation.

The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •Age ≥18 years.
  • •Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
  • •Patients planned for coronary angiography or PCI.
  • •Patients able to provide written informed consent.
  • •Patient is willing to comply with all study protocol required evaluations.
  • •Palpable radial pulse both at conventional and distal puncture site.
  • •Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization.

排除标准

  • •Acute ST-segment elevation myocardial infarction.
  • •Cardiogenic shock.
  • •Chronic hemodialysis.
  • •Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
  • •Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
  • •Patients unable to provide written informed consent.

研究组 & 干预措施

Distal radial access conventional guidance

Active Comparator

干预措施: Conventional guidance (Procedure)

Distal radial access

Experimental

干预措施: Distal radial potassium ferrate hemostatic patch (Device)

Conventional transradial access

Active Comparator

干预措施: Transradial potassium ferrate hemostatic patch (Device)

Distal radial access ultrasound-guided

Experimental

干预措施: Ultrasound-guidance (Procedure)

结局指标

主要结局

Hemostasis duration.

时间窗: From end of procedure to end of hemostasis (25 minutes for distal radial access and 60 minutes for conventional transradial access)

Access success

时间窗: Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed (on average 1 minute)

Access success occurs when an introducer sheath can be properly placed through the punctured artery.

次要结局

未报告次要终点

研究者

发起方
Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory A. Sgueglia

Principal Investigator

S.Eugenio Hospital

研究点 (6)

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