Prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHI
Not Applicable
Recruiting
- Conditions
- brain arteriovenous malformation
- Registration Number
- JPRN-UMIN000038303
- Lead Sponsor
- Kobe City Medical Center General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. impossible to use heparin 2. history of severe alergic reaction to contrast media 3. impossible to navigate microcatheter to ideal position 4. intolelance to provocative test 5. no distal flow by vasospasm 6. liver dysfunction (AST 120U or larger) or renal dysfunction (CRTN 2.0mg/dL or larger) 7. history of embolization using non-adhesive liquid material for target brain AVM 8. candidate to another approving trial 9. pregnant or possible to pregnancy lady 10. inappropriate patient for this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 50% or more volume reduction by embolization and no mortality within 30days after surgical resection
- Secondary Outcome Measures
Name Time Method 1. bleeding volume during surgical resection 2. duration of surgical resection 3. severe adverse event related to embolization 4. all mortality within 30days after embolization 5. all stroke within 30days after embolization 6. neurological deterioration within 30days after embolization 7. modified Rankin Scale 30days after embolization surgical resection