Endovascular Management of Pediatric Intracranial Arteriovenous Shunts

NCT03950258 | Completed

• 1 other identifier: Endovascular in pediatric
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Malformations; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

  within one week after treatment

Secondary Outcomes (1)

• Radiological outcome:

  Immediate post treatment and at 6 and 12 months post treatment

Study Arms (1)

endovascular embolization

EXPERIMENTAL

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

Procedure: endovascular embolization

Interventions

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.

endovascular embolization

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any patient above 18 years old
• Asymptomatic patients

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Arteriovenous Malformations; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama Ramadan, master

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: July 1, 2019
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)