Endovascular Management of Direct Carotid-cavernous Fistula

NCT06091150 | Unknown

• 1 other identifier: Soh-Med-23-9-10MS
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid-Cavernous Sinus Fistula

Outcome Measures

Primary Outcomes (2)

• 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 .

  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.

  6 months

Secondary Outcomes (1)

• Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters

  6 months

Study Arms (1)

Patients with direct carotid cavernous fistula

EXPERIMENTAL

Endovascular management using coils , detachable balloons or embolizing agents

Procedure: Endovascular management of direct carotid-cavernous fistula

Interventions

Endovascular management of direct carotid-cavernous fistula PROCEDURE

Coiling and embolization of direct carotid-cavernous fistula

Patients with direct carotid cavernous fistula

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with direct type of carotid cavernous fistula

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Ahmad Tharwat

Sohag, 28825, Egypt

RECRUITING

MeSH Terms

Conditions

Carotid-Cavernous Sinus Fistula

Condition Hierarchy (Ancestors)

Cavernous Sinus Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Carotid Artery Injuries; Cerebrovascular Trauma; Trauma, Nervous System; Arteriovenous Fistula; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

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: Resident physician

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)