NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000166

Registered date:13/09/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMoyamoya disease
Date of first enrollment2001/01/01
Target sample size160
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeThe 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 minimum16years-old
Age maximum65years-old
GenderMale and Female
Include criteria
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

Contact

public contact
Name Susumu Miyamoto
Address 5-7-1, Fujishirodai, Suita City, Osaka, Japan Japan
Telephone 06-6833-5012
E-mail
Affiliation National Cardiovascular Center Department of Neurosurgery, JAM Trial Office
scientific contact
Name Susumu Miyamoto
Address 5-7-1, Fujishirodai, Suita City, Osaka, Japan Japan
Telephone 06-6833-5012
E-mail
Affiliation National Cardiovascular Center Department of Neurosurgery