UMIN-CTR Clinical Trial

Basic information
Public title	Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402)
Acronym	Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils (SCIRO-1402)
Scientific Title	Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402)
Scientific Title:Acronym	Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils (SCIRO-1402)
Region	Japan

Condition
Condition	Pulmonary arteriovenous malformation
Classification by specialty	Pneumology Chest surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	efficacy
Key secondary outcomes	adverse event image findings

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Following doing pulmonary arteriography, venous sac embolization of pulmonary arteriovenous mulformations is to be performed using Hydrocoil. Embolization is performed in 1 procedure.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pulmonary arteriovenous malformation exists on chest CT (<= 3mm thickness) 2) Meets one or more following criteria. a) history of brain infarction and/or abscess b) history of transient ischemic attack c) history of hemoptysis d) history of hypoxemia e) diameter of feeding pulmonary artery >= 3mm. 3) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions. 4) Performans status of 0-2. 5) Life expectancy >= 13 months.
Key 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.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Kanazawa
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	+81-86-235-7315
Email	susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Iguchi
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	+81-86-235-7315
Homepage URL
Email	iguchi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Department of Radiology, Okayama University Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel	0862356938
Email	mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/31722843/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31722843/
Number of participants that the trial has enrolled	21
Results	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.
Results date posted	2021 Year 01 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients who met the criteria were enrolled in this study.
Participant flow	After determining whether patients met the criteria, all patients provided written informed consent. Thereafter, they participated in this study.
Adverse events	Two grade 1 (fever and noncardiac chest pain), three grade 2 (headache, atrial fibrillation, and cerebral infarction), and one grade 4 (coil migration).
Outcome measures	The primary endpoint was the efficacy of venous sac embolization using hydrogel-coated coils with additional feeding artery embolization. The secondary endpoint was safety.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 17 Day
Date of IRB	2014 Year 06 Month 17 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2018 Year 05 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 24 Day
Last modified on	2021 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016164