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MoyamoyaPhase 3AHMSSNCT02319980

The Adult Hemorrhagic Moyamoya Surgery Study

A Phase 3 study testing Extracranial-intracranial bypass surgery in people with Moyamoya and Stroke, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Moyamoya, Stroke
What is being tested?
Extracranial-intracranial bypass surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteChina
Study dates
May 2015to May 2023
Phase
Phase 3
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

  • Independent in activity of daily living(The modified Rankin Scale 0-2)
  • At least one month since the most recent hemorrhagic stroke
  • The neurological deficit must be stable for more than 6 weeks
  • Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan
  • Digital substraction angiography demonstrating progressive stenosis or occlusion in the terminal portion of the internal carotid artery and/or the initial portion of the anterior or middle cerebral arteries
  • Digital substraction angiography demonstrating formation of abnormal collateral networks(moyamoya vessels) at the base of the brain,mainly in the region of thalamus and basal ganglia
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  • Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally
  • Competent to give informed consent
  • Accessible and reliable for follow-up

Who cannot join

  • Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage
  • Not independent in activity of daily living(The modified Rankin Scale 3-5)
  • Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al)
  • Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle
  • Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
  • Emergent decompressive craniotomy causing automatically developed indirect revascularization
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  • Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery
  • Life expectancy<1 years
  • Pregnancy
  • Unstable angina or myocardial infarction with recent 6 months
  • Blood coagulation dysfunction
  • Allergic to iodine contrast agent
  • Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range)
  • Serum creatinine >3mg/dl
  • Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg)
  • Poor glucose control(fasting blood glucose>16.7mmol/l)
  • Concurrent participation in any other interventional clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Neurosurgery,Huashan Hospital,Fudan University

    Shanghai, 200040

Other trials in China

About this study

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Read the detailed description

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.

The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.

Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.

Conditions
Moyamoya, Stroke
Being tested
Extracranial-intracranial bypass surgery
Medical subject headings
Moyamoya Disease, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extracranial-intracranial bypass surgeryProcedure or surgery

    Also called STA-MCA Bypass and EDMS

    All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)

Study groups in NCT02319980
Study groupRoleWhat they receive
Surgical interventionActive comparatorAll participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
Receives: Procedure: Extracranial-intracranial bypass surgery
Conservative management(medical management)No interventionAll participants in this group will be assigned to receive conservative management or medical management which involves drug therapy as considered appropriate for medical symptoms by the treating investigator.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards

    The number of participants who suffer from all strokes \& death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization

    Measured: within 5 years of randomization

Secondary outcomes (6)

  1. All kinds of adverse events related to surgery

    The number of participants who suffer from all kinds of adverse events related to surgery within 30 days

    Measured: up to 30 days

  2. Rebleeding on the contralateral side

    The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization

    Measured: up to 5 years

  3. Transient ischemic attack on the surgically treated side

    The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization

    Measured: up to 5 years

  4. The changes from baseline in modified Rankin Scale (mRS)

    The changes from baseline in modified Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial

    Measured: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

  5. The changes from baseline in National Institute of Health Stroke Scale (NIHSS)

    The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial

    Measured: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

  6. The changes from baseline in modified Barthel Index

    The changes from baseline in modified Barthel Index at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial

    Measured: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study startMay 2015
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02319980
Sponsor's protocol ID
CAHMD 2014
Acronym
AHMSS
Status last verified
Feb 2016
First submitted
28 Nov 2014
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Miyamoto S, Yoshimoto T, Hashimoto N, Okada Y, Tsuji I, Tominaga T, Nakagawara J, Takahashi JC; JAM Trial Investigators. Effects of extracranial-intracranial bypass for patients with hemorrhagic moyamoya disease: results of the Japan Adult Moyamoya Trial. Stroke. 2014 May;45(5):1415-21. doi: 10.1161/STROKEAHA.113.004386. Epub 2014 Mar 25.

    PubMed 24668203

  • Derdeyn CP. Direct bypass reduces the risk of recurrent hemorrhage in moyamoya syndrome, but effect on functional outcome is less certain. Stroke. 2014 May;45(5):1245-6. doi: 10.1161/STROKEAHA.114.004994. Epub 2014 Mar 25. No abstract available.

    PubMed 24668205

  • Scott RM, Smith ER. Moyamoya disease and moyamoya syndrome. N Engl J Med. 2009 Mar 19;360(12):1226-37. doi: 10.1056/NEJMra0804622. No abstract available.

    PubMed 19297575

  • Kobayashi E, Saeki N, Oishi H, Hirai S, Yamaura A. Long-term natural history of hemorrhagic moyamoya disease in 42 patients. J Neurosurg. 2000 Dec;93(6):976-80. doi: 10.3171/jns.2000.93.6.0976.

    PubMed 11117870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extracranial-intracranial bypass surgery in people with Moyamoya and Stroke, run by Huashan Hospital 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 9 inclusion and 17 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 17 Feb 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards (time frame: within 5 years of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02319980, which also lists 4 linked publications.

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 17 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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