Back to resultsDirect Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
Primary Purpose
Moyamoya Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bypass surgery and indrect bypass surgery
Sponsored by
About this trial
This is an interventional treatment trial for Moyamoya Disease focused on measuring hemorrhagic moyamoya disease, bypass, indirect bypass
Eligibility Criteria
Inclusion Criteria:
- 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"
- patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.
- Patients requiring surgery
Exclusion Criteria:
- Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
- patients refused to participate in the study
Sites / Locations
- Beijing Tiantan Hospital Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
group 1 direct bypass
group 2 indirect bypass
Arm Description
direct bypass : patients recieve direct bypass treatment
indirect bypass: patients recieve indirect bypass treatment
Outcomes
Primary Outcome Measures
rebleeding events
Secondary Outcome Measures
ischemic events
postoperative compilications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02982135
Brief Title
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
Official Title
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
liuxingju
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease
Keywords
hemorrhagic moyamoya disease, bypass, indirect bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1 direct bypass
Arm Type
Other
Arm Description
direct bypass : patients recieve direct bypass treatment
Arm Title
group 2 indirect bypass
Arm Type
Other
Arm Description
indirect bypass: patients recieve indirect bypass treatment
Intervention Type
Other
Intervention Name(s)
bypass surgery and indrect bypass surgery
Intervention Description
bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes
Primary Outcome Measure Information:
Title
rebleeding events
Time Frame
5-10 years
Secondary Outcome Measure Information:
Title
ischemic events
Time Frame
5-10 years
Title
postoperative compilications
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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"
patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.
Patients requiring surgery
Exclusion Criteria:
Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
patients refused to participate in the study
Facility Information:
Facility Name
Beijing Tiantan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
0086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liu xingju, MD
Phone
008615011476305
Email
liuxingju006@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
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