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临床试验/NCT04232488
NCT04232488Unknown不适用

Comparison of the Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach in Coronary Angiography and PCI

University Hospital "Sestre Milosrdnice"0 个研究点目标入组 750 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
750
主要终点
Occlusion of the radial artery

研究概览

简要总结

The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach

详细描述

Introduction

The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions, which is particularly suitable for patients with renal disease (for preservation of the radial artery due to the potential formation of AV fistula for dialysis) and progressive coronary disease in order to preserve the radial artery for aortocoronary bypass formation. It is also potentially less likely to develop compartment syndrome and is suitable for patients with reduced forearm mobility. Since wrist immobilization during hemostatic compression is not required, the use of a distal radial approach allows for early mobilization of patients and a shorter duration of compression itself.

Aim of the study: To compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach Purpose of the study: to confirm the efficacy of the distal radial approach as equally effective with a lower degree of radial artery occlusion during the follow-up period Research Hypothesis: Patients using a coronary angiography / percutaneous intervention using a distal radial approach had less occlusion of the radial arteries at long-term follow-up, with no significant difference in the features of the angiography / intervention itself (duration of procedure, time to obtain the vascular access, amount of contrast used , time and amount of radiation, procedure success).

Study participants: patients undergoing coronary intervention at the Catheterization Laboratory of the Clinic for Cardiovascular Diseases at the Clinical Hospital Center "Sestre milosrdnice", Zagreb Research Methodology and Material: Standard materials and standard methods will be used to perform coronary angiography and percutaneous coronary intervention Research Plan: After signing the informed consent, the study will include 250 patients in the distal transradial approach group, and 500 patients in the proximal radial approach group (control group). The materials, as well as the procedure technique, are standardized; the characteristics of the procedure (duration of the procedure, time of obtaining the arterial access, amount of contrast used, time and amount of radiation, success of the procedure) will be observed and Doppler of the radial artery will be performed on the first following operator-specified control (usually after 3 months of the procedure) to determine the patency of the artery.

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

入选标准

  • signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse

排除标准

  • hemodynamic instability, critically ill patient, usual coronary angiography contraindication

结局指标

主要结局

Occlusion of the radial artery

时间窗: 3 months

Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler

次要结局

未报告次要终点

研究者

发起方
University Hospital "Sestre Milosrdnice"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikola Kos

University Hospital

University Hospital

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