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临床试验/NCT03611725
NCT03611725已完成不适用

Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction

Wonju Severance Christian Hospital6 个研究点 分布在 2 个国家目标入组 352 人开始时间: 2018年8月15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
352
试验地点
6
主要终点
Puncture success rate (%)

研究概览

简要总结

ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 20 years
  • ST-segment elevation myocardial infarction
  • Palpable unilateral distal radial and radial artery

排除标准

  • Cardiogenic shock
  • Thrombolysis before primary percutaneous coronary intervention
  • Inability to obtain written informed consent
  • Patient with ipsilateral arteriovenous fistula
  • Participation in another ongoing clinical trial
  • Pregnancy
  • Expected lifespan <12 months
  • * Eligible operator criteria
  • Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture

结局指标

主要结局

Puncture success rate (%)

时间窗: Through procedure completion, up to 6 hours

The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group.

次要结局

  • Success rate of coronary angiography (%)(Through procedure completion, up to 6 hours)
  • Success rate of percutaneous coronary intervention (%)(Through procedure completion, up to 6 hours)
  • Procedure success rate (%)(Through procedure completion, up to 6 hours)
  • Bleeding complication rate (%)(During hospitalization, up to 1 month)
  • Total procedure time (minutes)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic time (minute)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic dose (Gray/cm2)(Through procedure completion, up to 6 hours)
  • Puncture time (minute)(Through procedure completion, up to 6 hours)
  • Success rate of coronary angiography (%)(Through procedure completion, up to 6 hours)
  • Success rate of percutaneous coronary intervention (%)(Through procedure completion, up to 6 hours)
  • Procedure success rate (%)(Through procedure completion, up to 6 hours)
  • Bleeding complication rate (%)(During hospitalization, up to 1 month)
  • Total procedure time (minutes)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic time (minute)(Through procedure completion, up to 6 hours)
  • Total fluoroscopic dose (Gray/cm2)(Through procedure completion, up to 6 hours)
  • MACE (%)(1 month)
  • Puncture time (minute)(Through procedure completion, up to 6 hours)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung Hwan Lee

Professor

Wonju Severance Christian Hospital

研究点 (6)

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