The Adult Hemorrhagic Moyamoya Surgery Study

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Independent in activity of daily living(The modified Rankin Scale 0-2)

• At least one month since the most recent hemorrhagic stroke

• The neurological deficit must be stable for more than 6 weeks

• Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan

• Digital substraction angiography demonstrating progressive stenosis or occlusion in the terminal portion of the internal carotid artery and/or the initial portion of the anterior or middle cerebral arteries

• Digital substraction angiography demonstrating formation of abnormal collateral networks(moyamoya vessels) at the base of the brain,mainly in the region of thalamus and basal ganglia

• Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally

• Competent to give informed consent

• Accessible and reliable for follow-up

Locations
Other Locations
China
Department of Neurosurgery,Huashan Hospital,Fudan University
Shanghai
Time Frame
Start Date: 2015-05
Completion Date: 2023-05
Participants
Target number of participants: 360
Treatments
Active_comparator: Surgical intervention
All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
No_intervention: Conservative management(medical management)
All participants in this group will be assigned to receive conservative management or medical management which involves drug therapy as considered appropriate for medical symptoms by the treating investigator.
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov

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