UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062688 |
|---|---|
| Receipt number | R000071773 |
| Scientific Title | Optimize Outcomes of Hemorrhagic Medium Sized AVMs Using Radiosurgery Followed by Feeder Embolization |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/25 20:58:39 |
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Basic information
Public title
Outcomes of Gamma Knife Radiosurgery Followed by Feeder Embolization for Hemorrhagic Medium-Sized Arteriovenous Malformations
Acronym
HMAVM-GKFE Study
Scientific Title
Optimize Outcomes of Hemorrhagic Medium Sized AVMs Using Radiosurgery Followed by Feeder Embolization
Scientific Title:Acronym
HMAVM-GKFE Study
Region
| Japan |
Condition
Condition
Hemorrhagic medium-sized cerebral arteriovenous malformation
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of feeder embolization following single-session stereotactic radiosurgery (SRS) for hemorrhagic medium-sized cerebral arteriovenous malformations by assessing reduction in hemorrhage rate, hemorrhage volume, and mortality risk, as well as shortening of the time to complete obliteration and improvement in the obliteration rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemorrhage rate within 12 months after feeder embolization following single-session stereotactic radiosurgery (SRS) for hemorrhagic medium-sized cerebral arteriovenous malformations with a nidus volume of 5 cm3 or greater and less than 10 cm3.
Key secondary outcomes
1. Complete obliteration rate of the arteriovenous malformation
2. Hemorrhage rate and hemorrhage-related mortality
3. Incidence of symptomatic adverse radiation effects (AREs)
4. Repeat SRS rate
5. Complications associated with embolization (incidence and severity)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-session Gamma Knife stereotactic radiosurgery (SRS) is performed for hemorrhagic medium-sized cerebral arteriovenous malformations, followed, if possible within 1 month, by a single session of feeder embolization using a liquid embolic agent or coils. The SRS margin dose is 17-20 Gy.
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
1. Patients with a history of hemorrhage from a medium-sized cerebral arteriovenous malformation (AVM), with a nidus volume of 5 cm3 or greater and less than 10 cm3 (approximately 2-3 cm in diameter), diagnosed by MRI, MRA, or cerebral angiography
2. Patients aged 18 years or older at the time of informed consent
3. Patients who provide written informed consent of their own free will after receiving sufficient explanation regarding participation in the study
Key exclusion criteria
1. Patients with hemorrhage from the AVM within 1 month before enrollment (patients with a history of hemorrhage more than 1 month previously are not excluded)
2. Patients who have previously received treatment for the AVM, including endovascular treatment, surgery, or radiation therapy
3. Patients with vascular or cerebral diseases that may interfere with invasive treatment, including cervical arterial stenosis or occlusion, or a history of brain surgery or cranial irradiation for other reasons
4. Patients with a baseline modified Rankin Scale (mRS) score of 4 or higher
5. Patients with a concomitant disease associated with a life expectancy of less than 10 years
6. Patients with thrombocytopenia (platelet count <100,000/uL) or a coagulation disorder (INR >1.5)
7. Pregnant or breastfeeding patients
8. Patients enrolled in another clinical trial, including a trial involving an investigational drug
9. Patients with a known allergy to iodinated contrast media
10. Patients with multiple AVMs
11. Patients diagnosed with vein of Galen malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or a neurocutaneous syndrome such as von Hippel-Lindau disease, Sturge-Weber syndrome, or Wyburn-Mason syndrome
12. Patients with an AVM associated with moyamoya-type changes or hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome)
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-machi, Shimotsuga-gun, Tochigi 321-0293, Japan
TEL
0282-86-1111
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
321-0293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, Japan
TEL
0282-86-1111
Homepage URL
h-kanou@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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 Institutional Review Board for Clinical Research
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
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071773
