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临床试验/NCT05340998
NCT05340998已完成不适用

Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study

Ospedale Sandro Pertini, Roma10 个研究点 分布在 1 个国家目标入组 1,357 人开始时间: 2022年7月15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
1,357
试验地点
10
主要终点
Vascular complications and major bleeding

研究概览

简要总结

All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access (TRA) will be screened for inclusion in this prospective observational study and patients with TRA failure necessitating vascular crossover will be included in the Registry after signing a dedicated written informed consent. A Control group of consecutive patients with radial access and without crossover will be included. Primary end point of the study is the rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups

详细描述

All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial approach (TRA) will be screened for inclusion in this prospective observational study and patients with TRA failure necessitating vascular crossover will be included in the Registry after signing a dedicated written informed consent. A Control group of consecutive patients with radial access and without crossover will be enrolled (2:1 rate compared to crossover group to avoid possible selection bias) after signing a dedicated written informed consent.

The modality of radial puncture (needle vs cannula), the choice of radial sheath (long vs short; hydrophilic vs non hydrophilic), the type of catheters employed, the use of spasmolytic agents and the choice of secondary vascular access will be left to the operator discretion.

According to the selected secondary access, patients will be divided in two groups: patients with a secondary (or tertiary) wrist access (total wrist Group) and patients with a crossover to femoral (Femoral Group). Patients included in the total wrist group may have a secondary access to the ulnar artery (ipsilateral or contralateral) or to the contralateral radial.

All patients will be checked during the procedure, immediately after and 24 hour post to evaluate possible vascular complications and bleeding.

Patient baseline characteristics, hospital data, comorbid conditions and complications will be recorded in a dedicated electronic case report form.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access

排除标准

  • Lack of signed informed consent, age <18 years

结局指标

主要结局

Vascular complications and major bleeding

时间窗: up to seven days

The rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups

次要结局

  • Minor bleeding(up to seven days)

研究者

发起方
Ospedale Sandro Pertini, Roma
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Sciahbasi, MD

Principal Investigator

Ospedale Sandro Pertini, Roma

研究点 (10)

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