dural arteriovenous fistula
Conditions
Interventions
trans-arterial embolization using PHIL
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. dural arteriovenous fistula 2. difficult to cure with trans-venous embolization 3. 4 or less of modified Rankin Scale 4. exist feeding artery candidate to trans-arteri al embolization 5. 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 idea l position 4. intolelance to provocative test 5. no distal flow by vasospasm 6. liver dysfunction (AST 120U or larger) or re nal dysfunction (CRTN 2.0mg/dL or larger) 7. history of embolization using non-adhesive li quid 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 |
|---|---|
| curative occlusion at 180 days after embolization and no pprocedure related mortality, stroke and severe hemorrhagic event within 30days after surgical resection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. recanalization at 180 days after embolization 2. re-treatment related to recanalization at 180 days after embolization 3. neurological symptoms related to recanalization at 180 days after embolization 4. any death at 180 days after embolization 5. any stroke at 180 days after embolization 6, neurological deterioration at 180 days after embolization 7. modified Rankin Scale at 180 days after embolization | — |
Countries
Japan
Contacts
Public ContactChiaki Sakai
Kobe City Medical Center General Hospital Center for Clinical Research and Innovation
Outcome results
None listed