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

Phase 2

• Conditions: Pulmonary arteriovenous malformation

• Registration Number: JPRN-UMIN000014360
• Lead Sponsor: Okayama University Hospital

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-01
• Study Completion: 2018-05-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy

Secondary Outcome Measures

Name	Time	Method
adverse event image findings