The Adult Hemorrhagic Moyamoya Surgery Study

NCT ID: NCT02319980

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2023-05-31

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.

Detailed Description

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.

The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.

Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.

Conditions

Moyamoya; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical intervention

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

Group Type: ACTIVE_COMPARATOR

Extracranial-intracranial bypass surgery

Intervention Type: 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)

Conservative management(medical management)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Extracranial-intracranial bypass surgery

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)

Intervention Type: PROCEDURE

Other Intervention Names

STA-MCA Bypass and EDMS

Eligibility Criteria

Inclusion Criteria

1. Independent in activity of daily living(The modified Rankin Scale 0-2)

2. At least one month since the most recent hemorrhagic stroke

3. The neurological deficit must be stable for more than 6 weeks

4. Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan

5. 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

6. 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

7. Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally

8. Competent to give informed consent

9. Accessible and reliable for follow-up

Exclusion Criteria

1. Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage

2. Not independent in activity of daily living(The modified Rankin Scale 3-5)

3. Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al)

4. Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle

5. Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery

6. Emergent decompressive craniotomy causing automatically developed indirect revascularization

7. Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery

8. Life expectancy<1 years

9. Pregnancy

10. Unstable angina or myocardial infarction with recent 6 months

11. Blood coagulation dysfunction

12. Allergic to iodine contrast agent

13. Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range)

14. Serum creatinine >3mg/dl

15. Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg)

16. Poor glucose control(fasting blood glucose>16.7mmol/l)

17. Concurrent participation in any other interventional clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanqiang Jiang,MD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuxiang Gu, MD,PhD

Role: STUDY_CHAIR

Department of Neurosurgery,Huashan Hospital,Fudan University

Locations

Department of Neurosurgery,Huashan Hospital,Fudan University

Shanghai, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 24668203 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24668205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19297575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11117870 (View on PubMed)

Other Identifiers

CAHMD 2014

Identifier Type: -

Identifier Source: org_study_id