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Completed

NCT Number: NCT03950258

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.

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Key information

Conditions

Arteriovenous Malformations Arteriovenous Fistula Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular embolization

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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