Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
Primary Purpose
Arteriovenous Malformations, Arteriovenous Fistula
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endovascular embolization
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Malformations
Eligibility Criteria
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
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endovascular embolization
Arm Description
patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization
Outcomes
Primary Outcome Measures
Independent clinical outcome changes
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.
Secondary Outcome Measures
Radiological outcome:
CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03950258
Brief Title
Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
Official Title
Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Malformations, Arteriovenous Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endovascular embolization
Arm Type
Experimental
Arm Description
patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization
Intervention Type
Procedure
Intervention Name(s)
endovascular embolization
Intervention Description
Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.
Primary Outcome Measure Information:
Title
Independent clinical outcome changes
Description
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.
Time Frame
within one week after treatment
Secondary Outcome Measure Information:
Title
Radiological outcome:
Description
CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt
Time Frame
Immediate post treatment and at 6 and 12 months post treatment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Ramadan, master
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
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