NCT02982135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 5, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

November 20, 2016

Last Update Submit

December 2, 2016

Conditions

Moyamoya Disease

Keywords

hemorrhagic moyamoya diseasebypassindirect bypass

Outcome Measures

Primary Outcomes (1)

  • rebleeding events

    5-10 years

Secondary Outcomes (2)

  • ischemic events

    5-10 years

  • postoperative compilications

    30 days

Study Arms (2)

group 1 direct bypass

OTHER

direct bypass : patients recieve direct bypass treatment

Other: bypass surgery and indrect bypass surgery

group 2 indirect bypass

OTHER

indirect bypass: patients recieve indirect bypass treatment

Other: bypass surgery and indrect bypass surgery

Interventions

bypass surgery and indrect bypass surgeryOTHER

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

group 1 direct bypassgroup 2 indirect bypass

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
  • patients refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 0086, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 20, 2016

First Posted

December 5, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

December 5, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)