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Clinical Trials/JPRN-UMIN000014360
JPRN-UMIN000014360CompletedPhase 2

Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402) - Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils (SCIRO-1402)

Okayama University Hospital0 sites21 target enrollmentStarted: July 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
21

Study Overview

Brief Summary

Embolization was successfully completed in 20/21 pulmonary arteriovenous malformations (PAVMs). A technical failure occurred in one PAVM, where embolization was abandoned because of migration of one bare coil to the left ventricle. One patient with one PAVM was lost to follow-up after 3 months. Neither recanalization nor reperfusion was noted in the remaining 19 PAVMs (success rate, 19/19 [100%]). One grade 4 (coil migration) adverse event occurred, and it was treated without any sequelae.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
20years-old to ot applicable (—)
Sex
All

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1) History of allergy of iodinated contrast material 2) Active asthma 3) Single lung. 4) Inpaired pulmonary function of contralateral lung. 5) Pulmonary hypertension. 6) Estimated Glomerular Filtration Rate < 30min/mil (excluding dialysis) 7) Child Pugh score >= 9 8) Heart failure (NYHA >= III) 9) Uncontrolable malignant disease. 10) Active infection or active inflammatory process 11) Body temperature of 38 degree or more. 12) Pregnant. 13) Not eligible determined by the responding physician.

Investigators

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