Outcomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
Peripheral artery disease (PAD) affects >200 millionadults worldwide and is amajor cause of morbidity ranging from exertional lower extremity pain to ischemic rest pain and ulcer formation.
Endovascular treatment options for PAD have increased dramatically in the past several decades. The traditional endovascular treatment of severe PAD has been balloon angioplasty with or without adjunctive stenting.
The outcomes of balloon angioplasty and stenting are acceptable for short lesion lengths in the superficial femoral artery (SFA) and proximal popliteal arteries.Therefore, there is an established need for technologies that can adequately treat more complex femoropopliteal lesions.
Endovascular atherectomy has emerged as a novel technique for atheroma removal in patients with disease of the SFA or popliteal arteries. Atherectomy offers the advantages of surgical endarterectomy by removing atherosclerotic plaque while remaining a minimally invasive and percutaneous treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients present with CLTI due to femoropopliteal artery disease with the following criteria:
- •Denovo or Recoil
- •Stenosis or occlusion
排除标准
- •Patients present with:
- •Previous ipsilateral bypass surgery
- •In-stent restenosis or previous atherectomy
- •Known hypercoagulable disorder or non-atherosclerotic vasculopathy
- •Severe renal insufficiency (eGFR <30) not on dialysis
- •Inability to provide informed consent
结局指标
主要结局
Technical success
时间窗: From october 2025 to october 2027
completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in SFA at final angiography.
次要结局
未报告次要终点
研究者
Ahmed Hassan Ahmed Mohamed Elshimy
Outcomes of Endovascular Atherectomy in femoropopliteal arterial disease
Assiut University