The Adult Hemorrhagic Moyamoya Surgery Study

NCT02319980 | Unknown Phase 3 DMC

• 1 other identifier: CAHMD 2014
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Conditions

Moyamoya; Stroke

Outcome Measures

Primary Outcomes (1)

• All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards

  The number of participants who suffer from all strokes \& death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization

  within 5 years of randomization

Secondary Outcomes (6)

• All kinds of adverse events related to surgery

  up to 30 days

• Rebleeding on the contralateral side

  up to 5 years

• Transient ischemic attack on the surgically treated side

  up to 5 years

• The changes from baseline in modified Rankin Scale (mRS)

  at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

• The changes from baseline in National Institute of Health Stroke Scale (NIHSS)

  at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

Study Arms (2)

Surgical intervention

ACTIVE COMPARATOR

All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.

Procedure: Extracranial-intracranial bypass surgery

Conservative management(medical management)

NO INTERVENTION

All participants in this group will be assigned to receive conservative management or medical management which involves drug therapy as considered appropriate for medical symptoms by the treating investigator.

Interventions

Extracranial-intracranial bypass surgery PROCEDURE

All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)

Also known as: STA-MCA Bypass and EDMS

Surgical intervention

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 hemorrhagic stroke
• The neurological deficit must be stable for more than 6 weeks
• Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan
• 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 cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage
• 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)
• Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle
• 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

• Huashan Hospital: lead

Study Sites (1)

Department of Neurosurgery,Huashan Hospital,Fudan University

Shanghai, 200040, China

Location

Related Publications (4)

• Miyamoto S, Yoshimoto T, Hashimoto N, Okada Y, Tsuji I, Tominaga T, Nakagawara J, Takahashi JC; JAM Trial Investigators. Effects of extracranial-intracranial bypass for patients with hemorrhagic moyamoya disease: results of the Japan Adult Moyamoya Trial. Stroke. 2014 May;45(5):1415-21. doi: 10.1161/STROKEAHA.113.004386. Epub 2014 Mar 25.

  PMID: 24668203 BACKGROUND

• Derdeyn CP. Direct bypass reduces the risk of recurrent hemorrhage in moyamoya syndrome, but effect on functional outcome is less certain. Stroke. 2014 May;45(5):1245-6. doi: 10.1161/STROKEAHA.114.004994. Epub 2014 Mar 25. No abstract available.

  PMID: 24668205 BACKGROUND

• 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

• Kobayashi E, Saeki N, Oishi H, Hirai S, Yamaura A. Long-term natural history of hemorrhagic moyamoya disease in 42 patients. J Neurosurg. 2000 Dec;93(6):976-80. doi: 10.3171/jns.2000.93.6.0976.

  PMID: 11117870 BACKGROUND

MeSH Terms

Conditions

Moyamoya Disease; Stroke

Interventions

Cerebral Revascularization

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

Intervention Hierarchy (Ancestors)

Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Microsurgery

Study Officials

• Yuxiang Gu, MD,PhD

  Department of Neurosurgery,Huashan Hospital,Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 19, 2014
• Study Start: May 1, 2015
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (1)