Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Amputation free survival
研究概览
简要总结
Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these patients.
Most optimal vascular therapy mode has not been finally decided in these patients.
Therefore retrospective analysis of patients receiving open surgical and endovascular revascularisation was performed.
详细描述
Query of internal clinical database for identification of patients (2009-2017)with end-stage renal disease and critical limb ischemia, receiving either open surgical (Group I "OR") or endovascular revascularisation (Group II "EVT").
Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral run-off, plantar arch) and comorbidities.
Prospective follow-up of identified patients by means of telephone contacts and/or clinical examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free survival, wound healing)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of end-stage renal disease
- •presence of critical limb ischemia (Ankle-brachial-index > 0.4 or presence of rest pain or ischemic ulcers or gangrene)
- •revascularisation by means of Bypass or endovascular therapy
排除标准
- •conservative Treatment
- •non-atherosclerotic lesions
- •coagulation disorders
结局指标
主要结局
Amputation free survival
时间窗: 24 months
Evaluation of limb salvage and survival as Composite endpoint
次要结局
- Major Amputation(24 months)
- Overall survival(24 months)
研究者
Alexander Meyer, MD
MD
University Hospital Erlangen