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临床试验/NCT05461781
NCT05461781已完成不适用

Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion

Beijing Luhe Hospital1 个研究点 分布在 1 个国家目标入组 512 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
512
试验地点
1
主要终点
radial artery occlusion

研究概览

简要总结

Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

详细描述

Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.

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
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

  • Age ≥ 18 years
  • ST-segment elevation myocardial infarction for primary percuteous coronary intervention
  • Palpable pulses on both access sites of the radial artery
  • Informed consent

排除标准

  • Thrombolysis before primary percutaneous coronary intervention
  • Previous CABG or radio-cephalic fistula using radial artery
  • Cardiogenic shock
  • Severe arrhythmias
  • Severe liver and kidney dysfunction
  • Pregnancy
  • Enrolment in another study within 1 month
  • Inability to obtain written informed consent

结局指标

主要结局

radial artery occlusion

时间窗: at 24 hours after procedure

The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.

次要结局

  • the rate of successful puncture(Immediately post-procedurally)
  • radial aretry injury(Immediately post-procedurally)
  • major adverse cardiovascular events(MACE)(30 days after procedure)
  • puncture time(Immediately post-procedurally)
  • first medical contact to device (FMC2D) time(Immediately post-procedurally)
  • hand function(1 week after procedure)
  • access-related complications(at 24 hours after procedure)
  • hemostasis time(at 24 hours after procedure)
  • radial artery occlusion(30days after procedure)
  • procedural time(Immediately post-procedurally)

研究者

发起方
Beijing Luhe Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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