Moyamoya DiseasePBMNCT03516851
Precision Bypass in Patients With Moyamoya Disease
A study testing Precision bypass group in people with Moyamoya Disease, run by Peking University International Hospital at 2 sites in China.
Trial summary
Extracranial-intracranial arterial bypass, including anastomosis of the superficial temporal artery to the middle cerebral artery and indirect bypass, can help prevent further ischaemic attacks in patients with Moyamoya disease (MMD). 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?
- Precision bypass group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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
- Independent in activity of daily living(The modified Rankin Scale 0-2)
- At least one month since the most recent ischemic stroke
- The neurological deficit must be stable for more than 6 weeks
- 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
- 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 diseases(such as internal carotid artery stenosis, internal carotid artery dissection, atrial fibrillation, or Intracranial atherosclerosis) probably causing ischemic strokes
- 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)
- Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
- Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
- Emergent decompressive craniotomy causing automatically developed indirect revascularization
Show all 18Show fewer
- 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
- patients refused to participate in the study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 10050
Peking University International Hospital
Beijing, Beijing Municipality, 102200
About this study
Official title: Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease
Extracranial-intracranial arterial bypass, including anastomosis of the superficial temporal artery to the middle cerebral artery and indirect bypass, can help prevent further ischaemic attacks in patients with Moyamoya disease (MMD). However, there is no established standard for the selection of the recipient vessels. In most situations, surgeons choose the recipient vessels with their own experiences. Intraoperative Indocyanine green (ICG) angiography using Flow800 software and multimodal neuronavigation can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue for better selection of the recipient vessels. Thus the aim of this study is to to determine whether direct bypass surgery combined with multimodal neuronavigation is superior to traditional direct bypass procedure alone in adult ischemic MMD patients.
Read the detailed description
There are no effective medical therapies for moyamoya disease. Through the provision of collateral pathways, surgical revascularisation is the most successful therapy to improve cerebral haemodynamics, and to reduce the risk of subsequent stroke. Surgical procedures for moyamoya disease can be classified into three categories: direct bypass, indirect bypass, and combined bypass. Although surgeons have their own experience choosing the recipient vessels,no standard has been established based on a worldwide consensus.
Intraoperative ICG angiography using Flow800 software and multimodal neuronavigation (structure combined with perfusion MRI sequence) can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue, which is contribute to choose a recipient vessels with relative low cerebral blood flow velocity and perfusion.
Therefore,the PBM study in our institution is designed to compare the direct bypass surgery with multimodal neuronavigation with traditional direct bypass procedure alone in preventing any ischemic event afterwards after cerebral revascularization surgery in adult ischemic MMD patients.
- Conditions
- Moyamoya Disease
- Being tested
- Precision bypass group
- Keywords
- Moyamoya Disease, multimodal neuronavigation, flow800, direct revascularization
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision bypass groupProcedure or surgery
With the brain cortex exposed after craniotomy, an initial ICG fluorescence angiography will be performed. ICG fluorescence angiography using Flow800 software to determine blood flow velocity and cortical perfusion in different candidate receptors. And electromagnetic neuronavigation system is used to evaluate the cerebral flow under different candidate recipient vessels. The treatment planning station will be situated based on the multimodal neuronavigation data. The vessel was chose as the receptor with lower flow velocity and lower cerebral perfusion area to perform anastomosis. Then a direct bypass surgery will be performed just like in the empirical direct bypass surgery group.
| Study group | Role | What they receive |
|---|---|---|
| Precision bypass group | Active comparator | Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel Receives: Procedure: Precision bypass group |
| Empirical group | No intervention | choosing the recipient vessel by the surgeon's own experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic events
All strokes \& death within 30 days post-surgery and ipsilateral infarctions afterwards
Measured: 30 days
Secondary outcomes (7)
postoperative complications
All kinds of adverse events related to surgery within 30 days
Measured: 30 days
Infarctions
Infarctions on the contralateral side within 1 year of randomization
Measured: 1 years
Transient ischemic attack (TIA)
Transient ischemic attack on the surgically treated side within 1 year of randomization
Measured: 1 years
Cerebral Blood Flow (CBF)
The changes from baseline in CBF measured by arterial spin labeling (ASL) at 7days, 3 months, 6 months, 12 months or end of trial
Measured: at 7days, 3 months, 6 months, 12 months or end of trial
modified Rankin Scale (mRS)
The changes from baseline in modified Rankin Scale (mRS) at 7 days, 3 months, 6 months, 12 months or end of trial. The mRS ranges from 0-6. A mRS of 0-2 is identified as a favourable outcome, and a score of 3-6 as an unfavourable outcome.
Measured: at 7 days, 3 months, 6 months, 12 months or end of trial
National Institute of Health Stroke Scale (NIHSS)
The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 3 months, 6 months, 12 months or end of trial. A total score will be calculated and ranges from 0-42. A NIHSS of 0-14 is identified as a favourable outcome, and a score of 15-42 as an unfavourable outcome.
Measured: at 7 days, 3 months, 6 months, 12 months or end of trial
modified Barthel Index
The changes from baseline in modified Barthel Index at 7 days, 3 months, 6 months, 12 months or end of trial
Measured: at 7 days, 3 months, 6 months, 12 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.
- First posted4 May 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: there are not enough participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, yuanli Zhao，, Peking University International Hospital
- Investigators
- Xiaolin Chen, PhD, Study director, Beijing Tiantan HospitalJunlin Lu, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516851
- Sponsor's protocol ID
- pkuihsw1
- Acronym
- PBM
- Status last verified
- Mar 2021
- First submitted
- 21 Apr 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol of this study is to be shared
Publications
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 19297575Kuroda S, Houkin K. Moyamoya disease: current concepts and future perspectives. Lancet Neurol. 2008 Nov;7(11):1056-66. doi: 10.1016/S1474-4422(08)70240-0.
PubMed 18940695Wakai K, Tamakoshi A, Ikezaki K, Fukui M, Kawamura T, Aoki R, Kojima M, Lin Y, Ohno Y. Epidemiological features of moyamoya disease in Japan: findings from a nationwide survey. Clin Neurol Neurosurg. 1997 Oct;99 Suppl 2:S1-5. doi: 10.1016/s0303-8467(97)00031-0.
PubMed 9409395Caldarelli M, Di Rocco C, Gaglini P. Surgical treatment of moyamoya disease in pediatric age. J Neurosurg Sci. 2001 Jun;45(2):83-91.
PubMed 11533532Suzuki J, Kodama N. Moyamoya disease--a review. Stroke. 1983 Jan-Feb;14(1):104-9. doi: 10.1161/01.str.14.1.104.
PubMed 6823678Baba T, Houkin K, Kuroda S. Novel epidemiological features of moyamoya disease. J Neurol Neurosurg Psychiatry. 2008 Aug;79(8):900-4. doi: 10.1136/jnnp.2007.130666. Epub 2007 Dec 12.
PubMed 18077479Lu J, Zhao Y, Ma L, Chen Y, Li M, Ye X, Wang R, Chen X, Zhao Y. Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial. BMJ Open. 2019 Mar 20;9(3):e025566. doi: 10.1136/bmjopen-2018-025566.
PubMed 30898819
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease
- ClinicalTrials.gov ID
- NCT03516851
- Acronym / sponsor ID
- PBM / pkuihsw1
- Conditions
- Moyamoya Disease
- Keywords
- Moyamoya Disease, multimodal neuronavigation, flow800, direct revascularization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: there are not enough participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking University International HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 May 2018 (actual)
- 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.
Extracranial-intracranial arterial bypass, including anastomosis of the superficial temporal artery to the middle cerebral artery and indirect bypass, can help prevent further ischaemic attacks in patients with Moyamoya disease (MMD). However, there is no established standard for the selection of the recipient vessels. In most situations, surgeons choose the recipient vessels with their own experiences. Intraoperative Indocyanine green (ICG) angiography using Flow800 software and multimodal neuronavigation can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue for better selection of the recipient vessels. Thus the aim of this study is to to determine whether direct bypass surgery combined with multimodal neuronavigation is superior to traditional direct bypass procedure alone in adult ischemic MMD patients.
Detailed description
There are no effective medical therapies for moyamoya disease. Through the provision of collateral pathways, surgical revascularisation is the most successful therapy to improve cerebral haemodynamics, and to reduce the risk of subsequent stroke. Surgical procedures for moyamoya disease can be classified into three categories: direct bypass, indirect bypass, and combined bypass. Although surgeons have their own experience choosing the recipient vessels,no standard has been established based on a worldwide consensus.
Intraoperative ICG angiography using Flow800 software and multimodal neuronavigation (structure combined with perfusion MRI sequence) can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue, which is contribute to choose a recipient vessels with relative low cerebral blood flow velocity and perfusion.
Therefore,the PBM study in our institution is designed to compare the direct bypass surgery with multimodal neuronavigation with traditional direct bypass procedure alone in preventing any ischemic event afterwards after cerebral revascularization surgery in adult ischemic MMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision bypass group | Active comparator | Procedure: Precision bypass groupUsing ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel |
| Empirical group | No intervention | –choosing the recipient vessel by the surgeon's own experience |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Independent in activity of daily living(The modified Rankin Scale 0-2)
- At least one month since the most recent ischemic stroke
- The neurological deficit must be stable for more than 6 weeks
- 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
Key exclusion criteria (18 listed)
- Other diseases(such as internal carotid artery stenosis, internal carotid artery dissection, atrial fibrillation, or Intracranial atherosclerosis) probably causing ischemic strokes
- 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)
- Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
- Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
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 |
|---|---|---|
| Precision bypass groupWith the brain cortex exposed after craniotomy, an initial ICG fluorescence angiography will be performed. ICG fluorescence angiography using Flow800 software to determine blood flow velocity and cortical perfusion in different candidate receptors. And electromagnetic neuronavigation system is used to evaluate the cerebral flow under different candidate recipient vessels. The treatment planning station will be situated based on the multimodal neuronavigation data. The vessel was chose as the receptor with lower flow velocity and lower cerebral perfusion area to perform anastomosis. Then a direct bypass surgery will be performed just like in the empirical direct bypass surgery group. | Procedure or surgery | Precision bypass group |
Primary outcome
ischemic events
Time frame: 30 days
All strokes \& death within 30 days post-surgery and ipsilateral infarctions afterwards
7 secondary outcomes
postoperative complications
Time frame: 30 days
Infarctions
Time frame: 1 years
Transient ischemic attack (TIA)
Time frame: 1 years
Cerebral Blood Flow (CBF)
Time frame: at 7days, 3 months, 6 months, 12 months or end of trial
modified Rankin Scale (mRS)
Time frame: at 7 days, 3 months, 6 months, 12 months or end of trial
National Institute of Health Stroke Scale (NIHSS)
Time frame: at 7 days, 3 months, 6 months, 12 months or end of trial
modified Barthel Index
Time frame: at 7 days, 3 months, 6 months, 12 months or end of trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 19297575Scott 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.
- Background: PubMed 18940695Kuroda S, Houkin K. Moyamoya disease: current concepts and future perspectives. Lancet Neurol. 2008 Nov;7(11):1056-66. doi: 10.1016/S1474-4422(08)70240-0.
- Background: PubMed 9409395Wakai K, Tamakoshi A, Ikezaki K, Fukui M, Kawamura T, Aoki R, Kojima M, Lin Y, Ohno Y. Epidemiological features of moyamoya disease in Japan: findings from a nationwide survey. Clin Neurol Neurosurg. 1997 Oct;99 Suppl 2:S1-5. doi: 10.1016/s0303-8467(97)00031-0.
- Background: PubMed 11533532Caldarelli M, Di Rocco C, Gaglini P. Surgical treatment of moyamoya disease in pediatric age. J Neurosurg Sci. 2001 Jun;45(2):83-91.
- Background: PubMed 6823678Suzuki J, Kodama N. Moyamoya disease--a review. Stroke. 1983 Jan-Feb;14(1):104-9. doi: 10.1161/01.str.14.1.104.
- Background: PubMed 18077479Baba T, Houkin K, Kuroda S. Novel epidemiological features of moyamoya disease. J Neurol Neurosurg Psychiatry. 2008 Aug;79(8):900-4. doi: 10.1136/jnnp.2007.130666. Epub 2007 Dec 12.
- Derived from this study: PubMed 30898819Lu J, Zhao Y, Ma L, Chen Y, Li M, Ye X, Wang R, Chen X, Zhao Y. Multimodal neuronavigation-guided precision bypass in adult ischaemic patients with moyamoya disease: study protocol for a randomised controlled trial. BMJ Open. 2019 Mar 20;9(3):e025566. doi: 10.1136/bmjopen-2018-025566.
- Individual participant dataSharing planned: Yes. The study protocol of this study is to be shared
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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.
Xiaolin Chen, PhD study director
Beijing Tiantan Hospital
Junlin Lu, MD study chair
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision bypass group in people with Moyamoya Disease, run by Peking University International Hospital at 2 sites 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ischemic events (time frame: 30 days). 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 NCT03516851, which also lists 7 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 10 Mar 2021.