跳至主要内容
临床试验/NCT06165406
NCT06165406招募中不适用

Distal Radial Access for Diagnostic and Interventional Coronary Procedures in an All-comer Population: Observational Registry

Hospital Arnau de Vilanova1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年8月1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
2,000
试验地点
1
主要终点
Vascular access success

研究概览

简要总结

Distal radial access (DRA) in the anatomical snuffbox (AS) is a relatively novel approach that can be considered an alternative to trans radial access (TRA) for coronary procedures. Several observational and randomized studies have established its feasibility and safety, with evidence of certain advantages over TRA, such as a reduction in hemostasis time, a lower incidence of complications at the puncture site, and a lower incidence of radial artery occlusion (RAO). Notwithstanding that a recent randomized study reported a similar RAO rate between DRA and TRA, several meta-analyzes confirm the advantages of DRA, despite a consistently higher crossover rate.

The objective of this observational study is to assess the performance of the procedure and to compare clinical characteristics in an all-comer population undergoing diagnostic or interventional coronary procedures.

The main questions it aims to answer are:

  • Determine the success rate of DRA and measure the incidence of RAO in an all-comer population undergoing coronary procedures.
  • Compare the clinical and anatomical characteristics of patients with DRA for coronary procedures and determine predictors of failure of access.

详细描述

Introduction In recent decades, trans radial access (TRA) through the proximal radial artery has become the standard access site for performing diagnostic and therapeutic coronary procedures, its advantages over trans femoral access being demonstrated through multiple studies. such as reduction in access site complications and even reduction in mortality, especially in higher-risk patients.

There are circumstances in which anatomical variants can limit the clinical benefits of TRA, generating complications such as radial artery occlusion (RAO), which is by far the most frequent complication of this access, with a higher incidence at 24 h and recanalization after 30 days in 50% of patients. The presence of RAO limits access to future procedures, if necessary. The incidence of RAO reported in experienced centers remains high.

Distal Radial Access (DRA) through the anatomical snuffbox of the hand is a technique that has emerged in recent years and has been consolidated in multiple multicenter studies and meta-analyses to obtain arterial access in patients undergoing coronary angiography. and coronary intervention, which reduces the incidence of RAO, in addition to reducing hemostasis times, favoring patient and operator comfort compared to TRA.

DRA requires a slightly higher learning curve than TRA due to certain anatomical characteristics, such as the size of the distal radial artery, its depth, the presence of tortuosities, and the specific anatomical structures surrounding it. The DRA technique initially described was based on anatomical references (conventional puncture), however, the introduction of ultrasound as a puncture tool allows the operator to identify the size and course of the artery, in addition to a better assessment of the anatomy of the artery. area, thus avoiding injuries to them.

Most of the registries and clinical trials conducted to date are single centers, so the conduct of collaborative studies is of interest to determine the usefulness of different types of arterial access in coronary procedures.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Vascular access success

时间窗: During the vascular access procedure.

Defined when the introducer sheath can be placed appropriately through the punctured artery.

次要结局

  • Access-related complications(At the end of the procedure (up to 6 hours).)
  • Exposure to ionizing radiation(At the end of the procedure (up to 5 minutes).)
  • Distal radial access time(During the vascular access procedure)
  • Total procedure time(Throughout the procedure)
  • Patient comfort during vascular access.(Throughout the procedure)
  • Radial artery spasm(Throughout the procedure)

研究者

发起方
Hospital Arnau de Vilanova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristian Rivera

Principal Investigator

Hospital Arnau de Vilanova

研究点 (1)

Loading locations...

相似试验