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Endovascular versus drug therapy to symptomatic middle cerebral artery (MCA) stenosis

Randomised controlled trial of Symptomatic Middle cerebral artery (MCA) stenosis: Endovascular versus Drug therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62985634
Enrollment
166
Registered
2008-10-29
Start date
2008-01-01
Completion date
Unknown
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial atherosclerotic stenosis Circulatory System Occlusion and stenosis

Interventions

Drug therapy: Clopidogrel 75 mg and aspirin 100 mg every day (QD), maintaining such a plan for 3 months. After that, aspirin 100 mg or clopidogrel 75 mg should be retained.

Sponsors

Beijing Municipal Science and Technology Commission (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1. The patient died or experienced stroke within 30 days after the beginning of treatment 2. The stent does not cover the lesion or stenosis can't be retrieved completely (less than 50%)

Secondary

MeasureTime frame
DSA should be performed after six months if the patient receives endovascular therapy or the patient experiences stroke which is related to the target vessel.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026