Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Vascular Access Time
研究概览
简要总结
The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.
详细描述
Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.
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
- 否
入选标准
- •Patients over 18 years
- •Clinical indication for coronary angiography / angioplasty
- •Palpable radial and distal radial pulse
- •Previous clinical Barbeau test
- •Radial and distal radial patency via vascular ultrasound
- •24-hour and 30-day follow-up feasibility
排除标准
- •Previous vascular punctions in the studied anatomic site
- •Artery introductor relationship
- •Arteriovenous fistula
- •Current treatment with oral anticoagulants
- •Contraindication for Heparin
- •Incomplete medical records
- •Vascular access sheath - radial artery mismatch
- •Distal radial or ulnar fracture history
结局指标
主要结局
Vascular Access Time
时间窗: Seconds during the procedure
Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.
次要结局
- Distal Radial Artery Occlusion(In the first 24 hours, and follow up to 30 days)
- "Conventional" Radial Artery Occlusion(In the first 24 hours, and follow up to 30 days)
研究者
Manuel Alonso Abril Lee
Interventional Cardiology Consultant
Instituto Mexicano del Seguro Social