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Trial record 10 of 66 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Precision Bypass in Patients With Moyamoya Disease (PBM)

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ClinicalTrials.gov Identifier: NCT03516851
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
yuanli Zhao,, Peking University International Hospital

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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Procedure: Precision bypass group Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Precision bypass group
Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel
Procedure: Precision bypass group
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.

No Intervention: Empirical group
choosing the recipient vessel by the surgeon's own experience



Primary Outcome Measures :
  1. ischemic events [ Time Frame: 30 days ]
    All strokes & death within 30 days post-surgery and ipsilateral infarctions afterwards


Secondary Outcome Measures :
  1. postoperative complications [ Time Frame: 30 days ]
    All kinds of adverse events related to surgery within 30 days

  2. Infarctions [ Time Frame: 1 years ]
    Infarctions on the contralateral side within 1 year of randomization

  3. Transient ischemic attack (TIA) [ Time Frame: 1 years ]
    Transient ischemic attack on the surgically treated side within 1 year of randomization

  4. Cerebral Blood Flow (CBF) [ Time Frame: at 7days, 3 months, 6 months, 12 months or end of trial ]
    The changes from baseline in CBF measured by arterial spin labeling (ASL) at 7days, 3 months, 6 months, 12 months or end of trial

  5. modified Rankin Scale (mRS) [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]
    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.

  6. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]
    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.

  7. modified Barthel Index [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]
    The changes from baseline in modified Barthel Index at 7 days, 3 months, 6 months, 12 months or end of trial



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516851


Contacts
Contact: Yuanli Zhao, MD +8613801121203 zhaoyuanli@126.com
Contact: Rong Wang, PhD +8613001190333 ronger720102@aliyun.com

Locations
China, Beijing
Beijing Tiantan Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 10050
Contact: Yuanli Zhao, MD    +8613801121203    zhaoyuanli@126.com   
Contact: Rong Wang, PhD    13001190333    ronger720102@aliyun.com   
Principal Investigator: Yuanli Zhao, MD         
Sub-Investigator: Rong Wang, PhD         
Sub-Investigator: Xiaolin Chen, PhD         
Peking University International Hospital Recruiting
Beijing, Beijing, China, 102200
Contact: Xiaolin Chen, PhD    +8613810624845    xiaolinchen448@hotmail.com   
Contact: Junlin Lu, MD    +8618583638728    ljl147258@outlook.com   
Principal Investigator: Yuanli Zhao, MD         
Sub-Investigator: Rong Wang, MD         
Sub-Investigator: Xiaolin Chen, MD         
Sponsors and Collaborators
Peking University International Hospital
Beijing Tiantan Hospital
Investigators
Study Director: Xiaolin Chen, PhD Beijing Tiantan Hospital,Capital Medical University
Study Chair: Junlin Lu, MD Beijing Tiantan Hospital,Capital Medical University
  Study Documents (Full-Text)

Documents provided by yuanli Zhao,, Peking University International Hospital:
Study Protocol  [PDF] April 21, 2018


Publications:
Responsible Party: yuanli Zhao,, professor, Peking University International Hospital
ClinicalTrials.gov Identifier: NCT03516851     History of Changes
Other Study ID Numbers: pkuihsw1
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol of this study is to be shared
Supporting Materials: Study Protocol
Time Frame: from September 1, 2018 to September 1, 2019
Access Criteria: everyone
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yuanli Zhao,, Peking University International Hospital:
Moyamoya Disease
multimodal neuronavigation
flow800
direct revascularization

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases