ISRCTN14469736进行中（未招募）未知
Multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia due to atherosclerotic femoro-popliteal, with or without infra-popliteal involvement, peripheral arterial disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 481
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28526046 protocol
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or over
- •2. Have severe limb ischaemia due to femoro-popliteal, with or without infra-popliteal, peripheral artery disease
- •3. Be judged by the responsible clinicians (consultant vascular surgeon, interventional radiologist, diabetologist) working as part of a multidisciplinary team to require early endovascular femoro-popliteal, with or without infra-popliteal revascularisation in addition to best medical treatment, foot and wound care
- •4. Have adequate ‘inflow’ to support all possible trial revascularisation strategies
- •5. Be judged suitable for all possible trial revascularisation strategies following diagnostic imaging and a formal (documented) discussion by a multi-disciplinary team meeting
排除标准
- •1. Have an anticipated life expectancy <6 months
- •2. Are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity [Scotland] Act 2000)
- •3. Are a non-English speaker where translation facilities are insufficient to guarantee informed consent
- •4. Are judged unsuitable for any of the revascularisation strategies being evaluated
研究者
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