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临床试验/NCT03986151
NCT03986151已完成不适用

Anatomical sNuffbox for Coronary anGiography and IntervEntions

University Hospital of Patras2 个研究点 分布在 1 个国家目标入组 1,042 人开始时间: 2019年6月11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
1,042
试验地点
2
主要终点
Rate of right radial artery occlusion

研究概览

简要总结

This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.

详细描述

Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.

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
Single (Outcomes Assessor)

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

  • Indication for coronary angiography
  • Informed consent

排除标准

  • Non palpable right radial artery
  • Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
  • Prior CABG
  • Hemodynamic instability
  • Anatomical restrictions (fistula, etc)

结局指标

主要结局

Rate of right radial artery occlusion

时间窗: ≥30 days after CAG or PCI

次要结局

  • Rate of successful insertion of the sheath(Immediately post-procedurally)
  • Duration of sheath insertion procedure(Immediately post-procedurally)
  • Rate of successful completion of percutaneous coronary intervention(Immediately post-procedurally)
  • Total Procedure Time(Immediately post-procedurally)
  • Pain associated with the procedure: Pain scale 0-10(1 hour)
  • Rate of successful completion of coronary angiography(Immediately post-procedurally)
  • Total Fluoroscopy time(Immediately post-procedurally)
  • Rate of distal radial artery occlusion(≥30 days after CAG or PCI)
  • Total Contrast volume(Immediately post-procedurally)
  • Postprocedural Hematoma (modified EASY class)(3 hours)
  • Total Radiation Dose(Immediately post-procedurally)
  • Time required for hemostasis(1-6 hours)

研究者

发起方
University Hospital of Patras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Grigorios Tsigkas

Cardiology consultant

University Hospital of Patras

研究点 (2)

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