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

Moyamoya Disease Clinical Trial

Official title:

Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982135
• Other study ID #: BJTTH-003
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2016
• Last updated: December 2, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: November 2016
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Health authority: Beijing Tiantan Hospital,Capital Medical University:CHINA
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moyamoya Disease

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
liuxingju

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rebleeding events		5-10 years	Yes
Secondary	ischemic events		5-10 years	Yes
Secondary	postoperative compilications		30 days	Yes