Clinical trial NCT06091150: Endovascular Management of Direct Carotid-cavernous Fistula
Official title: Endovascular Management of Direct Carotid-cavernous Fistula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid-Cavernous Sinus Fistula
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 1
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Patients with direct type of carotid cavernous fistula

Exclusion Criteria:

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

Primary outcomes:
measure: Change in patient proptosis as measured by millimeters after endovascular interventional procedures
timeFrame: 6 months
measure: Change in patient visual acuity as assessed by Snellen chart
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ahmad Tharwat
Study officials:
References: