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Prospective registry trial of trans-arterial embolization for dural arteriovenous fistula using PHI

Not Applicable
Recruiting
Conditions
dural arteriovenous fistula
Registration Number
JPRN-UMIN000038325
Lead Sponsor
Kobe City Medical Center General Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
22
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 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
curative occlusion at 180 days after embolization and no pprocedure related mortality, stroke and severe hemorrhagic event within 30days after surgical resection
Secondary Outcome Measures
NameTimeMethod
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
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