Comparison of the "Serpentine" Technique Versus Hydrophilic Guidewire 0,035'' for Navigating Radial and Brachial Artery Loops, Tortuosity and Sharp Angulation During Transradial Access.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Successful crossing of anatomical obstacles and procedure completion
研究概览
简要总结
Coronary angiography and angioplasty are commonly performed through the radial artery. In some patients, anatomical variations of the radial and brachial arteries, such as loops, increased tortuosity or sharp angulations may pose challenges to equipment advancement.
Both the hydrophilic guidewire 0,035'' approach and the "Serpentine" technique have been described in the literature as techniques for overcoming radial anatomical challenges, with the hydrophilic guidewire approach being the more commonly used method.
In practical terms, both techniques involve the use of the same standard materials, with differences relating mainly to operator handling and technical manipulation. This study does not introduce any experimental device, material, or treatment; instead, it aims to compare the established approach using a 0.035'' hydrophilic guidewire with the emerging " Serpentine" technique with respect to effectiveness, procedural time, and safety.
详细描述
Transradial access (TRA) has become the preferred approach for diagnostic coronary angiography and percutaneous coronary intervention (PCI), compared with transfemoral access (TFA). Contemporary guidelines on revascularization in both chronic and acute coronary syndromes (ACS) recommend TRA as the first-line strategy, primarily due to its reduced risk of complications.
Additional advantages of TRA include improved cost-effectiveness, shorter intensive care unit stay, shorter overall hospitalization, faster patient mobilization, and greater patient comfort. TRA has also been associated with reduced contrast use and a lower risk of contrast-induced acute kidney injury.
Despite its advantages, TRA has limitations. It is associated with a modest increase in radiation exposure. A key drawback is the need for crossover to another access site, which is relatively common; however, this can be mitigated by operator experience and ultrasound guidance.
Anatomical variants are a major cause of procedural failure and crossover, occurring in 9-23% of patients. The most frequent variants include high origin of the radial artery from the brachial artery, arterial loops, and tortuosity of the radial or subclavian artery. Radial artery loops and severe tortuosity, observed in 4.2-13,1% of cases, are strongly associated with procedural failure (3.8-50%) and increased crossover rates. These anatomical challenges prolong procedural time, increase radiation exposure, and raise the risk of vascular complication.
Several techniques have been proposed to overcome these challenges. The most commonly adopted is the use of hydrophilic guidewires. Other techniques include mechanical straightening of tortuous segments from the operator, the use of angioplasty guidewires, microcatheters, balloon-assisted tracking (BAT), pigtail-assisted tracking (PAT), or switching to ulnar, transfemoral, or contralateral radial access.
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
- Single (Outcomes Assessor)
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
- •Age ≥18 years
- •Feasibility of TRA
- •Indication for coronary angiography
- •Angiographic documentation of radial or brachial artery loop/tortuosity
- •Written informed consent
排除标准
- •STEMI - high risk NSTEMI presentation
- •Hemodynamic instability
- •Anatomical contraindications (e.g., arteriovenous fistula)
- •Significant calcification of the radial or brachial artery on angiographic evaluation.
结局指标
主要结局
Successful crossing of anatomical obstacles and procedure completion
时间窗: During coronary angiography/PCI procedure, assessed up to 3 hours
Successful crossing of radial/brachial artery loops or tortuosity with completion of coronary angiography or PCI.
次要结局
- Total procedure time(During index procedure, assessed up to 3 hours.)
- Fluoroscopy time(During index procedure, assessed up to 3 hours.)
- Radiation exposure(During index procedure, assessed up to 3 hours.)
- Contrast volume used(During index procedure, assessed up to 3 hours.)
- Success rate of loop access per technique(During index procedure, assessed up to 3 hours.)
- Number of guidewires used(During index procedure, assessed up to 3 hours.)
- Number of catheters used(During index procedure, assessed up to 3 hours.)
- Radial artery spasm(During index procedure, assessed up to 3 hours.)
- Procedure-related symptoms(During index procedure, assessed up to 3 hours.)
- Access-site vascular complications(From procedure completion until discharge, assessed up to 7 days)
研究者
Grigorios Tsigkas
Tsigkas Grigorios pHD,Assistant proffessor of Cardiology at University Hospital of Patras
University Hospital of Patras