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Endovascular Management of Direct Carotid-cavernous Fistula

Endovascular Management of Direct Carotid-cavernous Fistula

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06091150
Enrollment
1
Registered
2023-10-19
Start date
2023-11-30
Completion date
2024-05-31
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid-Cavernous Sinus Fistula

Brief 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 (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

Interventions

PROCEDUREEndovascular management of direct carotid-cavernous fistula

Coiling and embolization of direct carotid-cavernous fistula

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with direct type of carotid cavernous fistula

Exclusion criteria

* End stage renal disease * haemodynamically unstable patients. * Patients with impaired coagulation profile.

Design outcomes

Primary

MeasureTime frameDescription
Change in patient proptosis as measured by millimeters after endovascular interventional procedures6 monthsChange 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 chart6 monthsChange in patient visual acuity assessed by Snellen chart and its comparison with patient pre-procedural vison acuity assessed by Snellen chart.

Secondary

MeasureTime frameDescription
Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters6 monthsChange 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 .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026