Endovascular Management of Direct Carotid-cavernous Fistula
Primary Purpose
Carotid-Cavernous Sinus Fistula
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endovascular management of direct carotid-cavernous fistula
Sponsored by
About this trial
This is an interventional treatment trial for Carotid-Cavernous Sinus Fistula
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.
Sites / Locations
- Ahmad TharwatRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with direct carotid cavernous fistula
Arm Description
Endovascular management using coils , detachable balloons or embolizing agents
Outcomes
Primary Outcome Measures
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 .
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.
Secondary Outcome Measures
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06091150
Brief Title
Endovascular Management of Direct Carotid-cavernous Fistula
Official Title
Endovascular Management of Direct Carotid-cavernous Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid-Cavernous Sinus Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with direct carotid cavernous fistula
Arm Type
Experimental
Arm Description
Endovascular management using coils , detachable balloons or embolizing agents
Intervention Type
Procedure
Intervention Name(s)
Endovascular management of direct carotid-cavernous fistula
Intervention Description
Coiling and embolization of direct carotid-cavernous fistula
Primary Outcome Measure Information:
Title
Change in patient proptosis as measured by millimeters after endovascular interventional procedures
Description
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 .
Time Frame
6 months
Title
Change in patient visual acuity as assessed by Snellen chart
Description
Change in patient visual acuity assessed by Snellen chart and its comparison with patient pre-procedural vison acuity assessed by Snellen chart.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of post-procedural change in superior ophthalmic vein caliber measured in millimeters
Description
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 .
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ahmad Tharwat
City
Sohag
ZIP/Postal Code
28825
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Tharwat, MBBCh
Phone
00201113797283
Email
ahmedtharwat33@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmad Tharwat
Phone
01099444441
Email
ahmadtharwat22@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All study and its results will be allowed in my institute website
Learn more about this trial
Endovascular Management of Direct Carotid-cavernous Fistula
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