Trial Outcomes & Findings for Fetal Treatment of Galenic Malformations (NCT NCT04434729)
NCT ID: NCT04434729
Last Updated: 2026-01-06
Results Overview
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
ACTIVE_NOT_RECRUITING
NA
7 participants
From fetal embolization to delivery
2026-01-06
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Fetal Treatment of Galenic Malformations
Baseline characteristics by cohort
| Measure |
Fetal Embolization of Vein of Galen Malformation
n=7 Participants
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.
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|---|---|
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Age, Continuous
|
32.4 years
n=9 Participants
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|
Sex: Female, Male
Female
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3 Participants
n=9 Participants
|
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Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From fetal embolization to deliveryPopulation: All 7 participants enrolled in the study.
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
Outcome measures
| Measure |
Fetal embolization of vein of Galen malformation
n=7 Participants
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.
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|---|---|
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Prenatal Safety of Fetal Embolization for Patients With Vein of Galen Malformations
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5 Participants
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SECONDARY outcome
Timeframe: Within 30 days of birthPopulation: All participants who successfully completed the embolization procedure.
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.
Outcome measures
| Measure |
Fetal embolization of vein of Galen malformation
n=5 Participants
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.
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|---|---|
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Efficacy of Fetal Embolization for Patients With Vein of Galen Malformations
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2 Participants
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Adverse Events
Fetal Embolization of Vein of Galen Malformation
Serious adverse events
| Measure |
Fetal Embolization of Vein of Galen Malformation
n=7 participants at risk
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.
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|---|---|
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Cardiac disorders
Sinus tachycardia, hypotension
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the time of enrollment through 2 years post-delivery.
The NCI-CTCAE v 5.0 system is used for maternal adverse events. The International Neonatal Consortium (INC) Neonatal Adverse Event Severity Scale is used for neonatal adverse events.
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Pregnancy, puerperium and perinatal conditions
Complete chorion-amnion separation
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14.3%
1/7 • Number of events 1 • Adverse events were collected from the time of enrollment through 2 years post-delivery.
The NCI-CTCAE v 5.0 system is used for maternal adverse events. The International Neonatal Consortium (INC) Neonatal Adverse Event Severity Scale is used for neonatal adverse events.
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Other adverse events
| Measure |
Fetal Embolization of Vein of Galen Malformation
n=7 participants at risk
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.
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|---|---|
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Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
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14.3%
1/7 • Number of events 1 • Adverse events were collected from the time of enrollment through 2 years post-delivery.
The NCI-CTCAE v 5.0 system is used for maternal adverse events. The International Neonatal Consortium (INC) Neonatal Adverse Event Severity Scale is used for neonatal adverse events.
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Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes (PPROM)
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14.3%
1/7 • Number of events 1 • Adverse events were collected from the time of enrollment through 2 years post-delivery.
The NCI-CTCAE v 5.0 system is used for maternal adverse events. The International Neonatal Consortium (INC) Neonatal Adverse Event Severity Scale is used for neonatal adverse events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place