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临床试验/NCT04080700
NCT04080700已完成不适用

Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)

Wonju Severance Christian Hospital14 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年9月9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
5,000
试验地点
14
主要终点
Success rate of coronary angiography

研究概览

简要总结

The left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. However, there is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. This prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

详细描述

Based on the results that radial approach (RA) reduced mortality and bleeding complications compared with femoral approach (FA), RA has become the standard of care for coronary angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018 ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding procedural considerations.

Operators usually prefer right RA because most of the operators are right-handed and right hand of the patient is closer to the operator. In contrast, longer distance to the left radial artery cause neck or back sprain of the operators, especially when the height of the operator is short, or the patient is obese. Nevertheless, left RA might be easier to manipulate catheter because of less tortuosity compared to the right RA and similar approach curvature with FA. Left RA also gives a chance to the right-handed patients to use their right hand freely.

Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. The left hand in the prone position is placed either on the left groin or beside the left hip according to operator preference. The operator punctures the distal radial artery around the anatomical snuffbox. After the first report for the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and 98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula. Several studies for DRA also showed similar favorable results regarding procedural success and bleeding complications.

Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can have a potential benefit in patients requiring arteriovenous fistula and in patients who need the radial artery as a conduit for coronary artery bypass graft because of the absence of radial injury.

There is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. Unknown complications related to DRA also should be addressed. Therefore, this prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients aged ≥ 20 years who planned coronary angiography
  • Patients with palpable distal radial artery
  • Patients who give informed consent

排除标准

  • Patients with small or non-palpable distal radial artery
  • Positive result in modified Allen test (suspicious of single blood supply)
  • Pregnant women, possible candidate for pregnancy, or breastfeeding women
  • Patients who are deemed unsuitable by the investigator

结局指标

主要结局

Success rate of coronary angiography

时间窗: Through procedure completion, up to 6 hours

Success rate of coronary angiography (%)

Success rate of percutaneous coronary intervention

时间窗: Through procedure completion, up to 6 hours

Success rate of percutaneous coronary intervention (%)

次要结局

  • Success rate of distal radial artery puncture(Through procedure completion, up to 6 hours)
  • Puncture-related complications(Up to 1 month)
  • Puncture time(Through procedure completion, up to 6 hours)
  • Hemostasis time(Through procedure completion, up to 24 hours)
  • Total procedure time(Through procedure completion, up to 6 hours)
  • Total fluoroscopic time(Through procedure completion, up to 6 hours)
  • Total fluoroscopic dose(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 (14)

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