Prospective Ramdomized Trial of Extracranial-intracranial (EC-IC) Bypass Surgery for Adults with Moyamoya Disease with Hemorrhagic Onset

UMIN ID: C000000166

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Moyamoya disease
• Date of first enrollment: 2001/01/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

EC-IC bypass on both sides (each side with some interval between). As the operative maneuver, the direct bypass procedures such as STA-MCA anastomosis are essential. A surgeon can add an indirect bypass procedure with direct bypass. Indirect bypass alone or high flow bypass graft such as venous graft or radial artery graft is not allowed.
Conservative therapy

Outcome(s)

• Primary Outcome: (1) recurrent bleeding (2) completed stroke causing significant morbidity in daily life activities (3) significant morbidity or mortality from other causes (4) the additional performance of EC-IC bypass by the decision of the participating neurologist such as in cases with progressive stroke, or crescendo TIA
• Secondary Outcome: The following events which occurs 3 months after enrollment: (1) recurrent bleeding on the same side of the previous bleeding (2) hemorrhage-related death or severe disability

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Not independent in daily lives (2) Atherosclerotic carotid disease, or cardiac arrhythmia which may cause thromboembolic complications (3) Malignant tumors or organ failure of the heart, liver, kidney, or lung (4) Unstable angina or has had a myocardial infarction within the past 6 months (5) Hematological abnormality showing bleeding diathesis (6) Uncontrolled diabetes showing a serum fasting blood glucose level of more than 300mg/dl, or requires insulin (7) Hypertension with the diastolic blood pressure of more than 110mmHg (8) Treated with EC-IC bypass surgery before enrollment (9) Pregnancy

Related Information

• Primary Sponsor: JAM Trial executive and steering committee
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare