UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062686 |
|---|---|
| Receipt number | R000071772 |
| Scientific Title | Optimize Outcomes of Large AVMs Using Radiosurgery Followed by Feeder Embolization |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/26 00:13:34 |
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Basic information
Public title
A Study of the Safety and Treatment Outcomes of Feeder Artery Embolization after Volume-Staged Gamma Knife Treatment for Large Cerebral Arteriovenous Malformations
Acronym
Large AVM Gamma Knife-Embolization Study
Scientific Title
Optimize Outcomes of Large AVMs Using Radiosurgery Followed by Feeder Embolization
Scientific Title:Acronym
AVM VSGK-FE Study
Region
| Japan |
Condition
Condition
Large cerebral arteriovenous malformation
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of feeder artery embolization following volume-staged Gamma Knife radiosurgery (GKRS) for large cerebral arteriovenous malformations, with particular focus on reducing hemorrhage during the latency period, shortening the time to complete obliteration, and improving the obliteration rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of AVM hemorrhage within 12 months after feeder embolization following volume-staged stereotactic radiosurgery for large cerebral arteriovenous malformations (nidus volume >=10 cm3)
Key secondary outcomes
Complete AVM obliteration rate
Time to complete AVM obliteration
Hemorrhage volume in patients who develop AVM hemorrhage
Mortality due to AVM hemorrhage
Incidence of symptomatic adverse radiation effects (ARE)
Rate of repeat stereotactic radiosurgery
Incidence and severity of complications associated with feeder embolization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with large cerebral arteriovenous malformations (nidus volume >=10 cm3) undergo volume-staged stereotactic radiosurgery (SRS) using Gamma Knife. The AVM nidus is divided into approximately two equal target volumes and treated in two stages, generally 3 months apart, with a marginal dose of 17-20 Gy at each stage. After completion of the second SRS stage, feeder artery embolization is performed in a single session, preferably within 1 month, under general anesthesia. A liquid embolic agent such as NBCA and/or coils is used to reduce AVM blood flow by occluding major feeding arteries. Intentional nidus embolization is avoided. Embolization of multiple feeders is permitted when considered safe.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a large cerebral arteriovenous malformation (AVM) with a nidus volume of 10 cm3 or greater diagnosed by MRI, MRA, or cerebral angiography.
Patients aged 18 years or older at the time of informed consent.
Patients who provide written informed consent voluntarily after receiving sufficient explanation of the study.
Key exclusion criteria
AVM hemorrhage within 1 month before enrollment.
Previous treatment for AVM, including endovascular treatment, surgery, or radiation therapy.
Vascular or intracranial disease that may interfere with invasive treatment.
Baseline modified Rankin Scale (mRS) score of 4 or greater.
A concomitant disease associated with a life expectancy of less than 10 years.
Platelet count below 100,000/uL or a coagulation disorder with INR >1.5.
Pregnancy or breastfeeding.
Enrollment in another clinical trial, including a clinical trial involving an investigational drug.
Known allergy to iodinated contrast media.
Multiple AVMs.
Vein of Galen malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or neurocutaneous syndromes such as von Hippel-Lindau disease, Sturge-Weber syndrome, or Wyburn-Mason syndrome.
AVM associated with moyamoya-type changes or hereditary hemorrhagic telangiectasia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kano |
Organization
Dokkyo Medical University Hospital
Division name
Department of Neurosurgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi 321-0293, Japan
TEL
+81-282-86-1111
h-kanou@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kano |
Organization
Dokkyo Medical University Hospital
Division name
Department of Neurosurgery
Zip code
320-0851
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi 321-0293, Japan
TEL
+81-282-86-1111
Homepage URL
h-kano@fj8.so-net.ne.jp
Sponsor or person
Institute
Dokkyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University Hospital
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
Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan
Tel
+81-282-87-2275
r-kenkyu@dokkyomed.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
| 2026 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prior to UMIN-CTR registration, a limited number of patients had been treated at the coordinating institution using the same therapeutic strategy. These patients are not included in the target sample size or in the prespecified primary analysis of the registered study. The registered study prospectively enrolls only patients who provide written informed consent after UMIN-CTR registration.
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071772
