Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

Arteriovenous Fistula Clinical Trial

Official title:

Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950258
• Other study ID #: Endovascular in pediatric
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Malformations
• Fistula

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within one week after treatment
Secondary	Radiological outcome:	CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt	Immediate post treatment and at 6 and 12 months post treatment