Carotid-Cavernous Sinus FistulaNCT06091150
Endovascular Management of Direct Carotid-cavernous Fistula
A study testing Endovascular management of direct carotid-cavernous fistula in people with Carotid-Cavernous Sinus Fistula, run by Sohag University at 1 site in Egypt.
Trial summary
Carotid-cavernous fistula (CCF) refers to an aberrant arteriovenous communication between the carotid arterial system and the venous compartments of the cavernous sinus (CS) Direct CCFs are when there is a direct fistulous connection between the cavernous sinus and cavernous segment of the internal carotid artery… Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Carotid-Cavernous Sinus Fistula
- What is being tested?
- Endovascular management of direct carotid-cavernous fistula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2023to May 2024
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with direct type of carotid cavernous fistula
Who cannot join
- End stage renal disease
- haemodynamically unstable patients.
- Patients with impaired coagulation profile.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmad Tharwat
Sohag, 28825
Ahmed Tharwat, MBBCh, 00201113797283, ahmedtharwat33@yahoo.com
Ahmad Tharwat, 01099444441, ahmadtharwat22@gmail.com
About this study
Carotid-cavernous fistula (CCF) refers to an aberrant arteriovenous communication between the carotid arterial system and the venous compartments of the cavernous sinus (CS) Direct CCFs are when there is a direct fistulous connection between the cavernous sinus and cavernous segment of the internal carotid artery (ICA), it is called direct or type-A CCF and occur secondary to a traumatic tear in the artery from a skull base fracture, from the acceleration-deceleration force of a traumatic injury, or from an iatrogenic injury following an endovascular intervention or a trans-sphenoidal procedure. They can also occur spontaneously following an ICA aneurysm rupture or weakening of the arteries from a genetic condition with subsequent development of chemosis, proptosis, bruit, headache, and/or gradual decrease in vision either unilaterally or bilaterally. High incidence of motor car accidents in Egypt carries a relative high incidence of carotid cavernous fistula. Since direct (type A) CCFs are high flow fistulas with acute/ subacute presentation and may cause serious complications, such as permanent vision loss or intracranial hemorrhage, they have to be treated early. CT orbit and MRI often help to confirm the initial diagnosis of CCF demonstrating extraoccularmuscleenlargement,dilatationofoneorbothsuperiorophthalmic veins and enlargement of the affected cavernous sinus.Because of its high spatial and temporal resolution ; the gold standard for evaluation of CCF is digital subtraction angiography; but currently CT angiography is the non invasive modality of choice for its evaluation .Previously surgical intervention included suturing or clipping the fistula, packing the cavernous sinus or ligating the internal carotid artery procedures .Currently endovascular management is the main stay of treatment for patients that fail or not suitable for conservative management and compression therapy. Significant advances in stent and catheter design now make it possible in many instances to deploy covered stents , detachable balloons, detachable coils, both detachable balloons and coils , both detachable and push coils , parent arterial occlusion and using of embolizing materials depending on availability, patient's affordability, type of fistula, and ease of use.Trans femoral catheterization is the main approach. However, trans-radial approach will be considered in patients with advanced iliofemoral diseases
- Conditions
- Carotid-Cavernous Sinus Fistula
- Being tested
- Endovascular management of direct carotid-cavernous fistula
- Medical subject headings
- Carotid-Cavernous Sinus Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular management of direct carotid-cavernous fistulaProcedure or surgery
Coiling and embolization of direct carotid-cavernous fistula
| Study group | Role | What they receive |
|---|---|---|
| Patients with direct carotid cavernous fistula | Experimental | Endovascular management using coils , detachable balloons or embolizing agents Receives: Procedure: Endovascular management of direct carotid-cavernous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient proptosis as measured by millimeters after endovascular interventional procedures
Change in patient proptosis measured in millimeters by ruler's test and by plain CT orbit after endovascular management and comparison with the degree of pre-procedural patient proptosis measured in millimeters .
Measured: 6 months
Change in patient visual acuity as assessed by Snellen chart
Change in patient visual acuity assessed by Snellen chart and its comparison with patient pre-procedural vison acuity assessed by Snellen chart.
Measured: 6 months
Secondary outcomes (1)
Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters
Change in the caliber of superior ophthalmic vein in millimeters and comparison with the contralateral symptom free side and its comparison with pre-procedural superior ophthalmic vein congestion measured in millimeters .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid-Cavernous Sinus FistulaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Tharwat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091150
- Sponsor's protocol ID
- Soh-Med-23-9-10MS
- Status last verified
- Nov 2023
- First submitted
- 30 Sep 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study and its results will be allowed in my institute website
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Management of Direct Carotid-cavernous Fistula
- ClinicalTrials.gov ID
- NCT06091150
- Acronym / sponsor ID
- Soh-Med-23-9-10MS
- Conditions
- Carotid-Cavernous Sinus Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 19 Oct 2023 (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.
Carotid-cavernous fistula (CCF) refers to an aberrant arteriovenous communication between the carotid arterial system and the venous compartments of the cavernous sinus (CS) Direct CCFs are when there is a direct fistulous connection between the cavernous sinus and cavernous segment of the internal carotid artery (ICA), it is called direct or type-A CCF and occur secondary to a traumatic tear in the artery from a skull base fracture, from the acceleration-deceleration force of a traumatic injury, or from an iatrogenic injury following an endovascular intervention or a trans-sphenoidal procedure. They can also occur spontaneously following an ICA aneurysm rupture or weakening of the arteries from a genetic condition with subsequent development of chemosis, proptosis, bruit, headache, and/or gradual decrease in vision either unilaterally or bilaterally. High incidence of motor car accidents in Egypt carries a relative high incidence of carotid cavernous fistula. Since direct (type A) CCFs are high flow fistulas with acute/ subacute presentation and may cause serious complications, such as permanent vision loss or intracranial hemorrhage, they have to be treated early. CT orbit and MRI often help to confirm the initial diagnosis of CCF demonstrating extraoccularmuscleenlargement,dilatationofoneorbothsuperiorophthalmic veins and enlargement of the affected cavernous sinus.Because of its high spatial and temporal resolution ; the gold standard for evaluation of CCF is digital subtraction angiography; but currently CT angiography is the non invasive modality of choice for its evaluation .Previously surgical intervention included suturing or clipping the fistula, packing the cavernous sinus or ligating the internal carotid artery procedures .Currently endovascular management is the main stay of treatment for patients that fail or not suitable for conservative management and compression therapy. Significant advances in stent and catheter design now make it possible in many instances to deploy covered stents , detachable balloons, detachable coils, both detachable balloons and coils , both detachable and push coils , parent arterial occlusion and using of embolizing materials depending on availability, patient's affordability, type of fistula, and ease of use.Trans femoral catheterization is the main approach. However, trans-radial approach will be considered in patients with advanced iliofemoral diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with direct carotid cavernous fistula | Experimental | Procedure: Endovascular management of direct carotid-cavernous fistulaEndovascular management using coils , detachable balloons or embolizing agents |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with direct type of carotid cavernous fistula
Key exclusion criteria (3 listed)
- End stage renal disease
- haemodynamically unstable patients.
- Patients with impaired coagulation profile.
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 management of direct carotid-cavernous fistulaCoiling and embolization of direct carotid-cavernous fistula | Procedure or surgery | Patients with direct carotid cavernous fistula |
Primary outcome
Change in patient proptosis as measured by millimeters after endovascular interventional procedures
Time frame: 6 months
Change in patient proptosis measured in millimeters by ruler's test and by plain CT orbit after endovascular management and comparison with the degree of pre-procedural patient proptosis measured in millimeters .
Change in patient visual acuity as assessed by Snellen chart
Time frame: 6 months
Change in patient visual acuity assessed by Snellen chart and its comparison with patient pre-procedural vison acuity assessed by Snellen chart.
1 secondary outcome
Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Yes. All study and its results will be allowed in my institute website
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.
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 management of direct carotid-cavernous fistula in people with Carotid-Cavernous Sinus Fistula, run by Sohag 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 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient proptosis as measured by millimeters after endovascular interventional procedures (time frame: 6 months). The study lists 2 primary outcomes in all. 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 14 Nov 2023.