Moyamoya DiseaseNCT02982135
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
A study testing bypass surgery and indrect bypass surgery in people with Moyamoya Disease, run by liuxingju at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- bypass surgery and indrect bypass surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
- patients refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 0086
liu xingju, MD, 008615011476305, liuxingju006@163.com
About this study
Official title: Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study
The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.
- Conditions
- Moyamoya Disease
- Being tested
- bypass surgery and indrect bypass surgery
- Keywords
- hemorrhagic moyamoya disease, bypass, indirect bypass
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bypass surgery and indrect bypass surgeryOther
bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes
| Study group | Role | What they receive |
|---|---|---|
| group 1 direct bypass | Other | direct bypass : patients recieve direct bypass treatment Receives: Other: bypass surgery and indrect bypass surgery |
| group 2 indirect bypass | Other | indirect bypass: patients recieve indirect bypass treatment Receives: Other: bypass surgery and indrect bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding events
Measured: 5-10 years
Secondary outcomes (2)
ischemic events
Measured: 5-10 years
postoperative compilications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liuxingju
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, liuxingju, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982135
- Sponsor's protocol ID
- BJTTH-003
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT02982135
- Acronym / sponsor ID
- BJTTH-003
- Conditions
- Moyamoya Disease
- Keywords
- hemorrhagic moyamoya disease, bypass, indirect bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- liuxingjuOther government
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 direct bypass | Other | Other: bypass surgery and indrect bypass surgerydirect bypass : patients recieve direct bypass treatment |
| group 2 indirect bypass | Other | Other: bypass surgery and indrect bypass surgeryindirect bypass: patients recieve indirect bypass treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
- patients refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bypass surgery and indrect bypass surgerybypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes | Other | group 1 direct bypass, group 2 indirect bypass |
Primary outcome
rebleeding events
Time frame: 5-10 years
2 secondary outcomes
ischemic events
Time frame: 5-10 years
postoperative compilications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beijing Tiantan Hospital Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bypass surgery and indrect bypass surgery in people with Moyamoya Disease, run by liuxingju at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rebleeding events (time frame: 5-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.