Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03950258

Collaborator

(none)

Enrollment

Location

Arm

10.2

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Malformations Arteriovenous Fistula	Procedure: endovascular embolization	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2019

Actual Primary Completion Date :

May 5, 2020

Actual Study Completion Date :

May 5, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Independent clinical outcome changes [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 Outcome Measures

Radiological outcome: [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Osama Ramadan, master, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

osama mahmoud ahmed ramadan, assistant lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT03950258

Other Study ID Numbers:

Endovascular in pediatric

First Posted:

May 15, 2019

Last Update Posted:

May 13, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arteriovenous Fistula

Arteriovenous Malformations

Fistula

Study Results

No Results Posted as of May 13, 2020