ISRCTN74370657已完成不适用
Prospective, multicentre, randomised double blinded evaluation of external beam radiation to prevent restenosis after femoropopliteal stenting to treat atherosclerotic stenosis or occlusion of femoropopliteal arteries
Hôtel-Dieu de Montréal (Canada)0 个研究点目标入组 214 人开始时间: 2006年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/07/2008:
- •1. 45 years and older, either sex
- •2. Femoropopliteal lesion greater than 4 cm above knee joint
- •3. Symptomatic lesion category 2 - 6 on Rutherford scale
- •4. Thrombosis or stenosis greater than 70% category A, B or C
- •5. Restenotic or de novo lesion, less than or equal to 20 cm
- •6. Ipsilateral ankle-brachial index (ABI) at rest less than or equal to 0.95
- •7. Written informed consent
- •Previous inclusion criteria:
- •1. 45 years and older, either sex
- •2. Femoropopliteal lesion greater than 4 cm above knee joint
- •3. Symptomatic lesion category 2 - 6 on Rutherford scale
- •4. Thrombosis or stenosis greater than 70% category A, B or C
- •5. Restenotic or de novo lesion, less than 15 cm
- •6. Ipsilateral ankle-brachial index (ABI) at rest less than or equal to 0.85
- •7. Written informed consent
排除标准
- •Current exclusion criteria as of 16/07/2008:
- •1. Contraindication to angiography or angioplasty or to clopidogrel
- •2. Recurrent lesion already treated by stenting
- •3. Prior irradiation or infection to the expected radiation site
- •4. Prior use of doxorubicine or other radiosensibilising agent
- •5. Patient susceptible to be pregnant
- •6. Hemodynamically significant lesion above the femoropopliteal lesion
- •7. Inhability to give informed consent or to complete the follow-up
- •8. Life expectancy of less than 2 years
- •9. Superficial femoral lesion treated with a view to a lower limb bypass initiated below site of femoro-popliteal endovascular revascularisation
- •10. Femoro-popliteal lesion located at least 2 cm below the groin (4 cm in the case of obese patients). For purposes of radiography the lesion should be located at 2 cm (4 cm in the case of obese patients) below the lower edge of the femoral head.
- •Previous exclusion criteria:
- •1. Contraindication to angiography or angioplasty or to clopidogrel
- •2. Recurrent lesion already treated by stenting
- •3. Prior irradiation or infection to the expected radiation site
- •4. Prior use of doxorubicine or other radiosensibilising agent
- •5. Patient susceptible to be pregnant
- •6. Hemodynamically significant lesion above the femoropopliteal lesion
- •7. Inhability to give informed consent or to complete the follow-up
- •8. Life expectancy of less than 2 years
研究者
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