Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries (RAFAL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Local complications
研究概览
简要总结
Thromboendarterectomy is the standard technique for the treatment of symptomatic occlusive lesions of the common femoral artery. It consists of surgically controlling the artery and interrupting circulation, opening the vessel and removing the atherosclerotic plaque. However, this technique is associated with healing difficulties, postoperative infections, and debilitating incisional pain. The rise of endovascular therapies, particularly at the coronary level, has led to the emergence of new deocclusion techniques, including rotational atherectomy. This technique relies on the use of an intravascular catheter that reams out the atherosclerotic plaque while re-aspirating the resulting debris. A few studies have examined the use of rotational atherectomy for occlusive lesions of the common femoral arteries, but have not evaluated its results compared to the standard treatment. The aim of this multicenter cohort is to describe the efficacy and safety of rotational atherectomy and the standard treatment, thromboendarterectomy, in symptomatic occlusive lesions affecting the common femoral artery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or female patient over 18 years of age
- •Non-emergency
- •Claudicating patient with significant de novo calcified stenosis affecting the common femoral artery, technically eligible for revascularization by thromboendarterectomy or rotational atherectomy
- •Surgery planned with either technique
- •Patient's consent to participate in the study must be obtained,
排除标准
- •Patient contraindicated for either technique (for surgical or anesthesiological reasons)
- •Patient with asymptomatic lesions of the common femoral artery
- •Patient with a history of surgery or angioplasty/stenting of the femoral stump
- •Patient with occlusion of the ipsilateral common femoral artery or external iliac artery
- •Patient with an indication for additional aortofemoral, iliofemoral, femoral-popliteal, or hamstring bypass
- •Patient with severe trophic disorders for which a major amputation is considered immediately in addition to revascularization
- •Patient objecting to the use of their data
结局指标
主要结局
Local complications
时间窗: one month
Local complications are defined as follows: hematoma, active bleeding, local infection, thrombosis, delayed healing, false aneurysm, arteriovenous fistula, and neuropathic pain following surgical trauma.
次要结局
未报告次要终点