Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study
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
- 否
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
Alessandro Sciahbasi, MD
Principal Investigator
Ospedale Sandro Pertini, Roma