UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014360 |
|---|---|
| Receipt number | R000016164 |
| Scientific Title | Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402) |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2021/01/21 17:53:43 |
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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
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
iguchi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016164
