Fetal Treatment of Galenic Malformations | NCT04434729

NCT04434729

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2020P000216	Other Identifier	Partners Healthcare IRB

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fetal embolization of vein of Galen malformation	Experimental	This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.	Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils	Device	The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations	The procedure is deemed safe if None of the following unacceptable events occur within 7 days of fetal embolization: Fetal death Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage. Maternal death None of the following unacceptable events occur between fetal embolization and delivery: Intra-procedural and post-procedural morbidity to the fetus and mother, probably related to the fetal intervention, e.g. placental abruption with subsequent sequelae Preterm delivery < 28 weeks, probably related to the fetal intervention Maternal blood transfusion or unanticipated surgical intervention, probably related to the fetal intervention Presence of fetal imaging evidence of new brain injury in a location or pattern unexpected for the natural history of vein of Galen malformation, probably related to the fetal intervention	From fetal embolization to delivery

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations	The procedure is deemed efficacious if none of the following serious postnatal events occur within 30 days of birth: Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention. Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort. Brain MRI within the first three weeks after birth reveals parenchymal brain injury (acute infarct or gliosis) affecting > 10% of the supratentorial brain volume. Without fetal intervention, we'd expect 30% of patients in this cohort to show this kind of injury.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal slice).
Fetal gestational age between 23 weeks and term as determined by clinical information and evaluation of first ultrasound.
Anatomic diagnosis of fetal vein of Galen malformation.
Well preserved brain parenchyma.
Maternal age of 18 years and older.
Eligible for continuous lumbar epidural anesthesia.
Able to travel to study site for study evaluation, procedures and visits.

Exclusion Criteria:

Extensive fetal brain parenchymal injury/gliosis, >10% of supratentorial brain volume (i.e., SFP presentation). This is a degree of fetal brain injury beyond which the risk of significant neurological morbidity is high, based on studies of prenatal ischemic stroke.
Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation), i.e., SFP presentation.
Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort.
Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater.
Fetuses with major congenital anomalies.
Evidence of preterm labor, rupture of membranes or abruption.
Maternal coagulopathy: INR > 1.2; PT/PTT above normal ranges for the lab; platelets <100.
Medical disease requiring current anticoagulation including maternal deep vein thrombosis.
Prior maternal medical history that would preclude epidural anesthesia.
Multi-fetal pregnancy.
Placenta previa or accreta.
Participation in another fetal study that influences maternal and fetal morbidity and mortality.
Known maternal hypersensitivity to 316LM stainless steel.
Supine hypotensive syndrome.

Name	Affiliation	Role
Darren Orbach, MD PhD	Boston Children's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40788723	Derived	Orbach DB, Shamshirsaz AA, Wilkins-Haug L, Guseh S, Krispin E, Tworetzky W, O'Leary B, Larson AM, Rangwala SD, Oushy S, See AP. In Utero Embolization for Fetal Vein of Galen Malformation. JAMA. 2025 Sep 9;334(10):878-885. doi: 10.1001/jama.2025.12363.
37139817	Derived	Orbach DB, Wilkins-Haug LE, Benson CB, Tworetzky W, Rangwala SD, Guseh SH, Gately NK, Stout JN, Mizrahi-Arnaud A, See AP. Transuterine Ultrasound-Guided Fetal Embolization of Vein of Galen Malformation, Eliminating Postnatal Pathophysiology. Stroke. 2023 Jun;54(6):e231-e232. doi: 10.1161/STROKEAHA.123.043421. Epub 2023 May 4. No abstract available.

Arm/Group Information

ID	Title	Description
FG000	Fetal Embolization of Vein of Galen Malformation	This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation. Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils: The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fetal Embolization of Vein of Galen Malformation	This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation. Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils: The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations

The procedure is deemed safe if

None of the following unacceptable events occur within 7 days of fetal embolization:
1. Fetal death
2. Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage.
3. Maternal death
None of the following unacceptable events occur between fetal embolization and delivery:
1. Intra-procedural and post-procedural morbidity to the fetus and mother, probably related to the fetal intervention, e.g. placental abruption with subsequent sequelae
2. Preterm delivery < 28 weeks, probably related to the fetal intervention
3. Maternal blood transfusion or unanticipated surgical intervention, probably related to the fetal intervention
4. Presence of fetal imaging evidence of new brain injury in a location or pattern unexpected for the natural history of vein of Galen malformation, probably related to the fetal intervention

All 7 participants enrolled in the study.

Posted

Count of Participants

Participants

From fetal embolization to delivery

ID	Title

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fetal Embolization of Vein of Galen Malformation	This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation. Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils: The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Sinus tachycardia, hypotension	Cardiac disorders	NCI-CTCAE v 5.0	Systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	NCI-CTCAE v 5.0	Systematic Assessment

ID	Term
D002538	Intracranial Arteriovenous Malformations
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases