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Multiple arachnoid Membrane Opening to Promote Angiogenesis in Adult MMD patients after combine bypass surgery, a multicenter randomized controlled clinical trial

Multiple arachnoid Membrane Opening to Promote Angiogenesis in Adult MMD patients after combine bypass surgery, a multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070323
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Moyamoya disease

Interventions

test group:Open arachnoid membrane during Moyamoya bypass surgery
control group:Do not open arachnoid membrane during Moyamoya bypass surgery

Sponsors

Neurosurgery, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Age ranging between 30 and 65 years 2. Digital subtraction angiography (DSA) imaging studies demonstrating MMD or MMS 3. Modified Rankin Scale (mRS) score 0–2 4. A qualifying transient ischaemic attack (TIA) or ischaemic stroke occurred within the past 12 months 6. The most recent stoke occurred more than 3 weeks previously 7. The neurological deficit must have been stable for more than 1 month 8. No massive cerebral infarction (more than 50%of the MCA territory) demonstrable in a CT or magnetic resonance imaging (MRI) study 9. CTP demonstrates misery perfusion (MTT more than 4 s and rCBF (symptomatic side/asymptomatic side) < 0.95) 10. Must be competent to give informed consent 11. Must be legally an adult 12. Must be geographically accessible and reliable for follow-up

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Other neurovascular disease (such as cerebral aneurysm or arteriovenous malformation) conditions likely to cause focal cerebral ischaemia 2. Known unstable angina or myocardial infarction within the last 6 months 3. Pregnant or perinatal stage women 4. Coagulopathy 5. Any diseases likely to lead to death within 2 years 6. Past history of EC-IC bypass surgery 7. Any contraindications or allergy to aspirin or clopidogrel 8. Any heart disease likely to cause cerebral ischaemia including prosthetic valve(s), infective endocarditis, atrial fibrillation, sick sinus syndrome, myxoma, and cardiomyopathy with an ejection fraction of less than 25% 9. Allergy to iodine or radiographic contrast media 10. Serum creatinine level > 3 mg/dl 11. Uncontrolled diabetes mellitus (fasting blood glucose level > 16.7 mmol/l) 12. Uncontrolled hypertension (systolic BP above 180 mmHg, diastolic BP above 110 mmHg) 13. Severe liver dysfunction (alanine transaminase (ALT) and/or aspartate transaminase (AST) more than three times the normal level) 14. Concurrent participation in any other experimental treatment trial 15. Any condition that in the surgeons judgment suggests the patient to be an unsuitable surgical candidate

Design outcomes

Primary

MeasureTime frame
Matsushima grade;

Secondary

MeasureTime frame
Surgical infection;subdural hematoma;hyper-perfusion syndrome;new brain infarction;

Countries

China

Contacts

Public ContactSongtao Qi

Neurosurgery, Nanfang Hospital, Southern Medical University

qisongtaosjwk@163.com+86 20 61641801

Outcome results

None listed

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