Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091150
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-09-30
Brief Title:
Endovascular Management of Direct Carotid-cavernous Fistula
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Endovascular Management of Direct Carotid-cavernous Fistula
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 extraoccularmuscleenlargementdilatationofoneorbothsuperiorophthalmic veins and enlargement of the affected cavernous sinusBecause 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 patients affordability type of fistula and ease of useTrans femoral catheterization is the main approach However trans-radial approach will be considered in patients with advanced iliofemoral diseases
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None