Precision Bypass in Patients With Moyamoya Disease

NCT03516851 | Withdrawn

• 1 other identifier: pkuihsw1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Moyamoya Disease

Keywords

Moyamoya Disease; multimodal neuronavigation; flow800; direct revascularization

Outcome Measures

Primary Outcomes (1)

• ischemic events

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

  30 days

Secondary Outcomes (7)

• postoperative complications

  30 days

• Infarctions

  1 years

• Transient ischemic attack (TIA)

  1 years

• Cerebral Blood Flow (CBF)

  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

Study Arms (2)

Precision bypass group

ACTIVE COMPARATOR

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

Procedure: Precision bypass group

Empirical group

NO INTERVENTION

choosing the recipient vessel by the surgeon's own experience

Interventions

Precision bypass group PROCEDURE

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.

Precision bypass group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University International Hospital: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 10050, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 102200, China

Location

Related Publications (7)

• 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.

  PMID: 19297575 BACKGROUND

• 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.

  PMID: 18940695 BACKGROUND

• 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.

  PMID: 9409395 BACKGROUND

• Caldarelli M, Di Rocco C, Gaglini P. Surgical treatment of moyamoya disease in pediatric age. J Neurosurg Sci. 2001 Jun;45(2):83-91.

  PMID: 11533532 BACKGROUND

• Suzuki J, Kodama N. Moyamoya disease--a review. Stroke. 1983 Jan-Feb;14(1):104-9. doi: 10.1161/01.str.14.1.104.

  PMID: 6823678 BACKGROUND

• 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.

  PMID: 18077479 BACKGROUND

• 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.

  PMID: 30898819 DERIVED

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaolin Chen, PhD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

• Junlin Lu, MD

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 4, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from September 1, 2018 to September 1, 2019
• Access Criteria: everyone

Locations

CN (2)