Arteriovenous MalformationsNCT03950258
Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
A study testing endovascular embolization in people with Arteriovenous Malformations and Arteriovenous Fistula, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Arteriovenous Malformations, Arteriovenous Fistula
- What is being tested?
- endovascular embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Any patient above 18 years old
- Asymptomatic patients
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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.
- Conditions
- Arteriovenous Malformations, Arteriovenous Fistula
- Being tested
- endovascular embolization
- Medical subject headings
- Arteriovenous Malformations, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular embolizationProcedure or surgery
Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.
| Study group | Role | What they receive |
|---|---|---|
| endovascular embolization | Experimental | patients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization Receives: Procedure: endovascular embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one week after treatment
Secondary outcomes (1)
Radiological outcome:
CT angiography or MR angiography will be done to show complete or in complete occlusion of the AV shunt
Measured: Immediate post treatment and at 6 and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2019
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osama mahmoud ahmed ramadan, Assiut University
- Investigators
- Osama Ramadan, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950258
- Sponsor's protocol ID
- Endovascular in pediatric
- Status last verified
- May 2020
- First submitted
- 13 May 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Management of Pediatric Intracranial Arteriovenous Shunts
- ClinicalTrials.gov ID
- NCT03950258
- Acronym / sponsor ID
- Endovascular in pediatric
- Conditions
- Arteriovenous Malformations, Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endovascular embolization | Experimental | Procedure: endovascular embolizationpatients under the age of 18 years with arteriovenous shunts manifested by systemic or neurological manifestations will undergo endovascular embolization |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Any patient above 18 years old
- Asymptomatic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular embolizationTransarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected. | Procedure or surgery | endovascular embolization |
Primary outcome
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. 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.
1 secondary outcome
Radiological outcome:
Time frame: Immediate post treatment and at 6 and 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Ramadan, master principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular embolization in people with Arteriovenous Malformations and Arteriovenous Fistula, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent clinical outcome changes (time frame: within one week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.