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Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
- Review the outcomes of the Endovascular management of pediatric intracranial arteriovenous shunts.
- Give an effective treatment for pediatric intracranial arteriovenous shunts and can detect the best method could be used and assess safety and efficacy of different endovascular techniques in treatment of different AV shunts.
- Improve the outcome of these patients and decease rate of recurrence and complications.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arteriovenous Malformations Arteriovenous Fistula | Procedure: endovascular embolization | Not Applicable |
Intracranial arteriovenous shunts (ICAVS) in young children are characterized by frequent high-flow fistulas. In association with high-flow fistulas and the physiological condition of the developing brain and heart, each ICAVS type tends to present at a certain age with unique symptoms.
Vein of Galen aneurysmal malformation (VGAM) and dural sinus malformation with arteriovenous (AV) shunt tend to present in the neonate with high output cardiac failure. In infancy, VGAM, pial arteriovenous fistula (AVF) and infantile dural AVF (DAVF) tend to present with hydrodynamic disorder such as macrocephaly, ventriculomegaly, prominent facial veins, and developmental delay.
Pial AVF, AV malformation, and infantile DAVF can present with focal neurological signs such as seizure or hemorrhage at older ages they are in the subpial space, as opposed to VGAM or DAVF, which are extrapial in location and tend to present with systemic symptoms .
Endovascular treatment is currently the first choice of treatment for most pediatric ICAVS. The treatment goal should be defined on a patient-by-patient basis, according to the unique physiological condition of the child.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Endovascular Management of Pediatric Intracranial Arteriovenous Shunts |
| Actual Study Start Date : | July 1, 2019 |
| Actual Primary Completion Date : | May 5, 2020 |
| Actual Study Completion Date : | May 5, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: endovascular embolization
patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization
|
Procedure: endovascular embolization
Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.
|
- Independent clinical outcome changes [ Time Frame: within one week after treatment ]
The changes in clinical condition of the patients will be assessed before and after treatment using modified Rankin scale, as the scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
- Radiological outcome: [ Time Frame: Immediate post treatment and at 6 and 12 months post treatment ]CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 1- clinical manifestation of AV shunt according to the pathology with radiological diagnosis by CT angiography or MRA 2- patient must be under 18 years old
Exclusion Criteria:
- Any patient above 18 years old
- Asymptomatic patients
| Egypt | |
| Faculty of medicine | |
| Assiut, Egypt, 71515 | |
| Principal Investigator: | Osama Ramadan, master | Assiut University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 13, 2019 | ||||
| First Posted Date ICMJE | May 15, 2019 | ||||
| Last Update Posted Date | May 13, 2020 | ||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||
| Actual Primary Completion Date | May 5, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Independent clinical outcome changes [ Time Frame: within one week after treatment ] The changes in clinical condition of the patients will be assessed before and after treatment using modified Rankin scale, as the scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Radiological outcome: [ Time Frame: Immediate post treatment and at 6 and 12 months post treatment ] CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endovascular Management of Pediatric Intracranial Arteriovenous Shunts | ||||
| Official Title ICMJE | Endovascular Management of Pediatric Intracranial Arteriovenous Shunts | ||||
| Brief Summary |
|
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| Detailed Description |
Intracranial arteriovenous shunts (ICAVS) in young children are characterized by frequent high-flow fistulas. In association with high-flow fistulas and the physiological condition of the developing brain and heart, each ICAVS type tends to present at a certain age with unique symptoms. Vein of Galen aneurysmal malformation (VGAM) and dural sinus malformation with arteriovenous (AV) shunt tend to present in the neonate with high output cardiac failure. In infancy, VGAM, pial arteriovenous fistula (AVF) and infantile dural AVF (DAVF) tend to present with hydrodynamic disorder such as macrocephaly, ventriculomegaly, prominent facial veins, and developmental delay. Pial AVF, AV malformation, and infantile DAVF can present with focal neurological signs such as seizure or hemorrhage at older ages they are in the subpial space, as opposed to VGAM or DAVF, which are extrapial in location and tend to present with systemic symptoms . Endovascular treatment is currently the first choice of treatment for most pediatric ICAVS. The treatment goal should be defined on a patient-by-patient basis, according to the unique physiological condition of the child. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: endovascular embolization
Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.
|
||||
| Study Arms ICMJE | Experimental: endovascular embolization
patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization
Intervention: Procedure: endovascular embolization
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 5, 2020 | ||||
| Actual Primary Completion Date | May 5, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03950258 | ||||
| Other Study ID Numbers ICMJE | Endovascular in pediatric | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | osama mahmoud ahmed ramadan, Assiut University | ||||
| Study Sponsor ICMJE | Assiut University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Assiut University | ||||
| Verification Date | May 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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