ISRCTN62985634已完成未知
Randomised controlled trial of Symptomatic Middle cerebral artery (MCA) stenosis: Endovascular versus Drug therapy
Beijing Municipal Science and Technology Commission (China)0 个研究点目标入组 70 人开始时间: 2008年10月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/23117724 (added 04/07/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 25 - 75 years old (both genders) - half/bilateral stenosis on the M1 segment of the MCA - which is related to the onset of the cerebral ischaemia
- •2. Digital subtraction angiography (DSA) should be performed to verify such points as follows:
- •2.1. The degree of vascular stenosis should be greater than or equal to 70%
- •2.2. The length of lesion should be within 10 mm
- •2.3. The diameter of distal vessel should be more than 2 mm
- •3. Asymptomatic vascular stenosis greater than or equal to 50%
- •4. Atherosclerotic stenosis
- •5. National Institutes of Health Stroke Score (NIHSS) less than 15, and modified Rankin Scale (mRS) less than or equal to 3
- •6. The patient should be tolerant to both of the anti-platelet drugs
- •7. The patient should not be pregnant
排除标准
- •1. Acute cerebral stroke occurs in the past one week, which is correlated to the vascular lesion
- •2. Those patients who have diseases of a haemorrhagic tendency
- •3. Anticipation of life span is within one year, especially in those patients who have a combined malignant disease
- •4. Acute dissecting aneurysm; vascular lesion is due to vasculitis, moya-moya disease, vasculopathy because of radiation, muscle fibrodysplasia
- •5. Calcification can be observed in the lesion segment, which is difficult to be dilated. Thrombus can be seen in the lumen of blood vessel.
- •6. Intracranial haematoma, tumour, brain arteriovenous malformation (BAVM), intracranial aneurysm (AM) (not including an AM whose diameter is less than 5 mm, and that is located in a different circle region)
- •7. Patients are excluded:
- •7.1. When there is a contraindication to heparin
- •7.2. When they are not tolerant to x-rays or anaesthesia
- •7.3. When their haemoglobin is less than 10 g/dL or their platelet is less than 100000/l
- •8. Patients who received thrombolysis in the past 24 hours
- •9. Symptomatic coronary artery disease, where revascularisation is needed
- •10. Surgical intervention has been performed in the last one month or will be performed in the next three months
- •11. Endovascular therapy was performed in the same target vessel previously
- •12. Multi-stenosis are found in the same target vessel, the degree of which is more than 50%
- •13. Stent-planting is hard to be performed because of the circuitry of the vessels
- •14. Symptomatic intracranial arterial stenosis is found not only in one vessel
研究者
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