An interventional study of Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils in Vein of Galen Malformations, sponsored by Darren Orbach. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Darren Orbach · Not applicable, Interventional, and Treatment
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
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. This procedure will take place in an obstetric OR at Brigham and Women's Hospital. Data will be collected every 4 weeks post-procedure until delivery, as per standard of care. Data regarding delivery and post-delivery status will also be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Darren Orbach is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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
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.
Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations
The procedure is deemed safe if 1. 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 2. 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
Time frame: From fetal embolization to delivery
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: 1. Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention. 2. Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort. 3. 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.
Time frame: Within 30 days of birth
| Milestone | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| Started | 7 |
| Completed | 5 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Physician decision | 1 |
The procedure is deemed safe if 1. 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 2. 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
| Participants | Fetal embolization of vein of Galen malformation |
|---|---|
| Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations | 5 |
The procedure is deemed efficacious if none of the following serious postnatal events occur within 30 days of birth: 1. Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention. 2. Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort. 3. 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.
| Participants | Fetal embolization of vein of Galen malformation |
|---|---|
| Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations | 2 |
Collected over Adverse events were collected from the time of enrollment through 2 years post-delivery.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fetal Embolization of Vein of Galen Malformation | 3/7 (42.9%) | 2/7 (28.6%) | 2/7 (28.6%) |
| Event | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| Sinus tachycardia, hypotensionCardiac disorders | 1/7 |
| Complete chorion-amnion separationPregnancy, puerperium and perinatal conditions | 1/7 |
| Event | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| Premature rupture of membranesPregnancy, puerperium and perinatal conditions | 1/7 |
| Preterm premature rupture of membranes (PPROM)Pregnancy, puerperium and perinatal conditions | 1/7 |
| Age, Continuous(years) | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| Mean | 32.4 (22 to 36) |
| Sex: Female, Male(Participants) | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| Female | 3 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Fetal Embolization of Vein of Galen Malformation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 3 |
| More than one race | 1 |
| Unknown or Not Reported | 2 |
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Vein of Galen Malformations
Darren Orbach