Precision Bypass in Patients With Moyamoya Disease

Not Applicable

Withdrawn

• Conditions: Moyamoya Disease
• Interventions: Procedure: Precision bypass group

• Registration Number: NCT03516851
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-04
• Study Start: 2018-08-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision bypass group	Precision bypass group	Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
postoperative complications	30 days	All kinds of adverse events related to surgery within 30 days
Infarctions	1 years	Infarctions on the contralateral side within 1 year of randomization
Cerebral Blood Flow (CBF)	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
modified Rankin Scale (mRS)	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.
National Institute of Health Stroke Scale (NIHSS)	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.
modified Barthel Index	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
Transient ischemic attack (TIA)	1 years	Transient ischemic attack on the surgically treated side within 1 year of randomization

Trial Locations

Locations (2)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China