Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528717
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGICS
Brief Summary:
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy
Detailed Description:
Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis Eversion carotid endarterectomy eCEA has proven effective as a surgical treatment modality In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver Usually the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive severe atherosclerotic process on the distal part of the extracranial internal carotid artery the presence of uncontrollable atherosclerotic plaque after endarterectomy and in cases when an exceptionally thin artery wall remains after endarterectomy
Several techniques have been described for substituting carotid bifurcation with a synthetic graft The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery CCA proximally and the internal carotid artery ICA distally by creating proximal and distal end-to-end anastomoses This technique requires ligation and exclusion of the external carotid ECA and the superior thyroid artery from circulation The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied Currently there are no recommendations regarding the administration of carotid bypass nor comparisons of these techniques
In this study the investigators are comparing a technique with graft interposition between endarterectomized CCA creation of side-to-end anastomosis and the distal segment of the ICA end-to-end anastomosis after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally Therefore the role of flow preservation through the ECA could be defined
Several techniques have been described for substituting carotid bifurcation with a synthetic graft The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery CCA proximally and the internal carotid artery ICA distally by creating proximal and distal end-to-end anastomoses This technique requires ligation and exclusion of the external carotid ECA and the superior thyroid artery from circulation The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied Currently there are no recommendations regarding the administration of carotid bypass nor comparisons of these techniques
In this study the investigators are comparing a technique with graft interposition between endarterectomized CCA creation of side-to-end anastomosis and the distal segment of the ICA end-to-end anastomosis after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally Therefore the role of flow preservation through the ECA could be defined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None