跳至主要内容
临床试验/NCT04194606
NCT04194606招募中不适用

CORRECT RADIAL RCT: CORonaRy Angiography and intErventions Via Distal vs Proximal aCcess - a Randomized Trial of Different Radial Puncture Sites

Dr. med. Karsten Schenke6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
6
主要终点
Lower rate of forearm radial artery occlusion (RAO)

研究概览

简要总结

The objective of the study is to determine that a coronary angiography (CAG) or percutaneous coronary intervention (PCI) via a distal puncture of the radial artery (distal transradial access, dTRA) leads to a lower rate of radial artery occlusion (RAO) while also showing that it has a similar success rate when compared to the traditional proximal (proximal transradial access, pTRA) puncture site.

详细描述

Cardiac catheterization is one of the most common invasive procedures worldwide. After demonstrating the superiority of the radial access over the femoral arterial approach, the radial artery puncture has become the first choice for elective and emergency coronary interventions. In addition to the often chosen access on the inside of the forearm, the course of the radial artery also allows a puncture further distal on the back of the hand. In the anatomical snuffbox, the diameter is still sufficient for the introduction of the usual sheath, however, the thrombogenic puncture at the proximal radial segment is avoided and a hemostasis by compression over the scaphoid is simplified.

This study is a prospective, open-label, randomized, multicenter study to systematically compare primary success rates and potential complications after distal transradial coronary angiography or coronary intervention versus proximal radial artery puncture over the wrist. Both puncture routes are well established in clinical routine and are used in both elective and emergency cardiac catheterization in the centers involved and worldwide. Systematic comparisons exist so far only in small series, but randomized and prospective data would be urgently needed in the frequent application. Both puncture sites are only 4-8 cm apart, so that many risks of a transradial examination (vascular injury and / or closure, perforation, spasm) are in principle common to both access sites.

The purpose of this study is to demonstrate the potential benefits of radial artery puncture in the back of the hand due to a reduced rate of chronic vascular occlusion compared to over the wrist, as well as complications (bleeding or nerve damage) and subjective tolerability ( Pain) systematically.

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

  • Written consent to participate in the study
  • Age ≥ 18 years
  • Indication for coronary angiography or coronary intervention
  • Palpable pulse of the proximal and distal radial artery on one or both arms

排除标准

  • Hemodynamic instability (according to the criteria of cardiogenic shock: Hf> 120 / min and RR syst <90 mmHg)
  • Intubated patients
  • Sonographic evidence of occlusion of both radial arteries
  • Pregnant or lactating women
  • Patients that are currently or have within the last 30 days participated in a clinical trial
  • Primarily planned bilateral radial access; e.g. in the context of a CTO recanalization
  • Patients who are in a dependency / employment/ relationship with the study doctor or center
  • Patients with bilateral hand or arm misalignment / paresis that makes a radial Access impossible
  • Patients who do not speak German or who are unable to understand the nature, significance or scope of the study

结局指标

主要结局

Lower rate of forearm radial artery occlusion (RAO)

时间窗: 30 days

Use of color doppler ultrasound to assess the patency of the radial artery used in the index procedure.

次要结局

  • Incidence of vasospasm(during the procedure)
  • Puncture success rate of the randomized puncture site(During the procedure)
  • Hematoma, bleeding and other complications(48 hours)
  • Use of standard questionaire to assess Hand function(30 days)
  • Access cross over rate(During the procedure)
  • Duration of puncture(During the procedure)
  • Use of standard questionaire to assess pain(30 days)

研究者

发起方
Dr. med. Karsten Schenke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Karsten Schenke

Oberarzt - Consultant

Asklepios Kliniken Hamburg GmbH

研究点 (6)

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