brain arteriovenous malformation
Conditions
Interventions
pre-surgical endovascular embolization using PHIL
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. brain arteriovenous malformation 2. indicated to surgical resection 3. 4 or less of modified Rankin Scale 4. 1 to 4 of Spetzler & Martin Grade 5. exist feeding artery candidate to trans-arterial embolization 6. obtain documented consent form
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% or more volume reduction by embolization and no mortality within 30days after surgical resection | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactChiaki Sakai
Kobe City Medical Center General Hospital Center for Clinical Research and Innovation
Outcome results
None listed