Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Puncture success rate
研究概览
简要总结
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice.
详细描述
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective, feasible, but associated with a risk of occlusion of the radial artery.
The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients.
This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach.
This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery.
Secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH score, pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
single blind during the analyze
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
- •Over 18 years old.
- •Hospitalized in the cardiology department of the military hospital of Tunis.
- •elective Percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach
- •Non-inclusion criteria:
- •not provided written informed consent
- •both radial arteries were used for prior catheterization
- •Under oral anticoagulation
- •Having coronary bypass surgery
- •Hemodynamic instability
- •contra-indication to the radial approach:
- •Orthopedic surgery: amputation
- •Severe burns of both upper limbs.
- •Radial artery pulse not palpable, negative modified Allen test or Barbeau classification type D
- •Identified radial vascular anomaly: stenosis, fistula, tortuosity not allowing passage of the catheter
排除标准
- •death within a short period of time after admission
- •PCI by the same puncture site will be performed within 30 days after the first puncture
- •lost to follow-up
结局指标
主要结局
Puncture success rate
时间窗: During the procedure
Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
Radial artery occlusion rate
时间窗: 30 days
Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
次要结局
- Crossover rate(During the procedure)
- Radial artery spasm(During the procedure)
- Duration of the puncture(During the procedure)
- QuickDASH questionnaire(30 days)
- Number of patients presenting hematoma(24 hours)
- Pain scale(24 hours)
- Operator satisfaction(at the end of the inclusion)