Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

NCT ID: NCT03950258

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-05-05

Brief Summary

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* 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

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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.

Conditions

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Arteriovenous Malformations Arteriovenous Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endovascular embolization

patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization

Group Type EXPERIMENTAL

endovascular embolization

Intervention Type PROCEDURE

Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

1. Any patient above 18 years old
2. Asymptomatic patients
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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osama mahmoud ahmed ramadan

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Ramadan, master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Endovascular in pediatric

Identifier Type: -

Identifier Source: org_study_id

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