A Prospective Randomized Study Comparing the Safety of Percutaneous and Open Brachial Access in the Endovascular Treatment of Peripheral Arterial Lesion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 246
- 试验地点
- 11
研究概览
简要总结
Endovascular treatment tends to replace open surgery in the management of peripheral arterial disease. Access via the common femoral artery remains the primary approach for peripheral arterial interventions. Brachial artery access has emerged as a valid alternative when femoral access is not feasible. Brachial access can be achieved either percutaneously or through an open surgical approach at the elbow.
A limited number of studies have reported complication rates associated with open and percutaneous brachial access in the treatment of peripheral arterial disease. These studies have shown higher complication rates for percutaneous access (ranging from 6% to 9%) compared with open brachial access (ranging from 1% to 2%). However, no direct comparison between the two approaches has been reported to date.
This study is the first to provide a direct, prospective, randomized comparison between open brachial access and percutaneous brachial 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
- 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
- •Age ≥ 18 years
- •Endovascular diagnostic or therapeutic procedure via the brachial approach compatible with a 5F to 7F introducer
- •Patient affiliated with a social security scheme
排除标准
- •Adult patient under legal guardianship or curatorship
- •Contraindication to endovascular treatment
- •History of brachial artery puncture within the past 1 month
- •History of open surgical approach at the elbow
- •Presence of a stent at the puncture site
- •Acute upper limb ischemia
- •Life expectancy of less than one month
- •Patient refusal to participate in the study
- •Allergy to aspirin or clopidogrel
- •Pregnant woman
- •Patients not speaking the French language, refusing or unable to comply with the follow-up proposed in the study
- •Requirement for another endovascular procedure or open surgery within 30 days following the BRAVO study procedure
