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Precision Bypass in Patients With Moyamoya Disease (PBM)

Primary Purpose

Moyamoya Disease

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Precision bypass group
Sponsored by
Peking University International Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moyamoya Disease focused on measuring Moyamoya Disease, multimodal neuronavigation, flow800, direct revascularization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University
  • Peking University International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Precision bypass group

Empirical group

Arm Description

Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel

choosing the recipient vessel by the surgeon's own experience

Outcomes

Primary Outcome Measures

ischemic events
All strokes & death within 30 days post-surgery and ipsilateral infarctions afterwards

Secondary Outcome Measures

postoperative complications
All kinds of adverse events related to surgery within 30 days
Infarctions
Infarctions on the contralateral side within 1 year of randomization
Transient ischemic attack (TIA)
Transient ischemic attack on the surgically treated side within 1 year of randomization
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
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.
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.
modified Barthel Index
The changes from baseline in modified Barthel Index at 7 days, 3 months, 6 months, 12 months or end of trial

Full Information

First Posted
April 21, 2018
Last Updated
March 8, 2021
Sponsor
Peking University International Hospital
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03516851
Brief Title
Precision Bypass in Patients With Moyamoya Disease
Acronym
PBM
Official Title
Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
there are not enough participants enrolled
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University International Hospital
Collaborators
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease
Keywords
Moyamoya Disease, multimodal neuronavigation, flow800, direct revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precision bypass group
Arm Type
Active Comparator
Arm Description
Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel
Arm Title
Empirical group
Arm Type
No Intervention
Arm Description
choosing the recipient vessel by the surgeon's own experience
Intervention Type
Procedure
Intervention Name(s)
Precision bypass group
Intervention Description
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.
Primary Outcome Measure Information:
Title
ischemic events
Description
All strokes & death within 30 days post-surgery and ipsilateral infarctions afterwards
Time Frame
30 days
Secondary Outcome Measure Information:
Title
postoperative complications
Description
All kinds of adverse events related to surgery within 30 days
Time Frame
30 days
Title
Infarctions
Description
Infarctions on the contralateral side within 1 year of randomization
Time Frame
1 years
Title
Transient ischemic attack (TIA)
Description
Transient ischemic attack on the surgically treated side within 1 year of randomization
Time Frame
1 years
Title
Cerebral Blood Flow (CBF)
Description
The changes from baseline in CBF measured by arterial spin labeling (ASL) at 7days, 3 months, 6 months, 12 months or end of trial
Time Frame
at 7days, 3 months, 6 months, 12 months or end of trial
Title
modified Rankin Scale (mRS)
Description
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.
Time Frame
at 7 days, 3 months, 6 months, 12 months or end of trial
Title
National Institute of Health Stroke Scale (NIHSS)
Description
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.
Time Frame
at 7 days, 3 months, 6 months, 12 months or end of trial
Title
modified Barthel Index
Description
The changes from baseline in modified Barthel Index at 7 days, 3 months, 6 months, 12 months or end of trial
Time Frame
at 7 days, 3 months, 6 months, 12 months or end of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin Chen, PhD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Junlin Lu, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10050
Country
China
Facility Name
Peking University International Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102200
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol of this study is to be shared
IPD Sharing Time Frame
from September 1, 2018 to September 1, 2019
IPD Sharing Access Criteria
everyone
Citations:
PubMed Identifier
19297575
Citation
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.
Results Reference
background
PubMed Identifier
18940695
Citation
Kuroda 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.
Results Reference
background
PubMed Identifier
9409395
Citation
Wakai 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.
Results Reference
background
PubMed Identifier
11533532
Citation
Caldarelli M, Di Rocco C, Gaglini P. Surgical treatment of moyamoya disease in pediatric age. J Neurosurg Sci. 2001 Jun;45(2):83-91.
Results Reference
background
PubMed Identifier
6823678
Citation
Suzuki J, Kodama N. Moyamoya disease--a review. Stroke. 1983 Jan-Feb;14(1):104-9. doi: 10.1161/01.str.14.1.104.
Results Reference
background
PubMed Identifier
18077479
Citation
Baba 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.
Results Reference
background
PubMed Identifier
30898819
Citation
Lu 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.
Results Reference
derived

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Precision Bypass in Patients With Moyamoya Disease

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