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

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ClinicalTrials.gov Identifier: NCT02982135
Recruitment Status : Unknown
Verified November 2016 by liuxingju, Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
liuxingju, Ministry of Science and Technology of the People´s Republic of China

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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Other: bypass surgery and indrect bypass surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
group 1 direct bypass
direct bypass : patients recieve direct bypass treatment
Other: bypass surgery and indrect bypass surgery
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
Other: bypass surgery and indrect bypass surgery
bypass surgery : patients recieved STA-MCA bypass indrect bypass surgery:patients recieved EDAS or mutiple bur holes




Primary Outcome Measures :
  1. rebleeding events [ Time Frame: 5-10 years ]

Secondary Outcome Measures :
  1. ischemic events [ Time Frame: 5-10 years ]
  2. postoperative compilications [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982135


Locations
China, Beijing
Beijing Tiantan Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 0086
Contact: liu xingju, MD    008615011476305    liuxingju006@163.com   
Sponsors and Collaborators
liuxingju

Responsible Party: liuxingju, Principal investigator, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT02982135     History of Changes
Other Study ID Numbers: BJTTH-003
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by liuxingju, Ministry of Science and Technology of the People´s Republic of China:
hemorrhagic moyamoya disease
bypass
indirect bypass

Additional relevant MeSH terms:
Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases