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Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease

NCT ID: NCT02982135

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

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The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.

Detailed Description

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Conditions

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Moyamoya Disease

Keywords

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hemorrhagic moyamoya disease bypass indirect bypass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1 direct bypass

direct bypass : patients recieve direct bypass treatment

Group Type OTHER

bypass surgery and indrect bypass surgery

Intervention Type OTHER

bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes

group 2 indirect bypass

indirect bypass: patients recieve indirect bypass treatment

Group Type OTHER

bypass surgery and indrect bypass surgery

Intervention Type OTHER

bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes

Interventions

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bypass surgery and indrect bypass surgery

bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate "moyamoya collaterals"
2. patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.
3. Patients requiring surgery

Exclusion Criteria

1. Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
2. patients refused to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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liuxingju

OTHER_GOV

Sponsor Role lead

Responsible Party

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liuxingju

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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liu xingju, MD

Role: primary

Other Identifiers

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BJTTH-003

Identifier Type: -

Identifier Source: org_study_id