The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy (AGICS)

Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Carotid Artery Diseases; Carotid Atherosclerosis
• Intervention / Treatment: Procedure: Carotid graft interposition

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Slobodan Pesic, MD; Phone Number: 00381616303360; Email: spesic90@gmail.com
• Study Contact Backup: Name: Jovan Petrovic, MD; Email: jovanpetrovic1997@gmail.com

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Institute for Cardiovascular Diseases Dedinje
    • Contact: Slobodan Pesic; Phone Number: 00381616303360; Email: spesic90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent carotid artery surgery due to atherosclerotic symptomatic and asymptomatic disease had graft interposition conducted due to unsuccessful endarterectomy.

Description

Inclusion Criteria:

• symptomatic carotid stenosis (> 50%)
• unilateral asymptomatic carotid stenosis (> 60%)
• bilateral asymptomatic carotid stenosis (> 60%)

Exclusion Criteria:

• carotid restenosis
• "major surgery" in previous 6 months
• previous brain trauma or surgery
• malignant disease
• epilepsy
• carotid artery aneurysm

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECA flow preserved group; Patients with carotid graft interposition after endarterectomy of the common carotid artery and external carotid artery with preserved flow through the external carotid artery by side-to-end proximal anastomosis.	Procedure: Carotid graft interposition; In patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery.; Other Names: Carotid artery graft replacement; Carotid replacement with Dacron graft
Ligated ECA group; Patients with carotid graft interposition and end-to-end anastomoses on the undiseased segments of the common (proximally) and internal (distally) carotid artery, with ligation of the external carotid artery.	Procedure: Carotid graft interposition; In patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery.; Other Names: Carotid artery graft replacement; Carotid replacement with Dacron graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periprocedural stroke and death	onset of new neurological deficit or death during perioperative period	30 days
myocardial infarction	development of new acute coronary events during perioperative period	30 days
stroke ipsilateral to the procedure	development of new neurological events that are pathophysiological atributable to the operated side	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
restenosis rate	restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography	through study completion, an average of 2 years
graft patency	primary and primary assisted	through study completion, an average of 2 years
patient survival	defining cause of death	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Institute for Cardiovascular Diseases "Dedinje"
• Investigators: Study Director: Srdjan Babic, MD PhD, Institute for Cardiovascular Diseases "Dedinje"

Publications and helpful links

General Publications

• Timaran CH, McKinsey JF, Schneider PA, Littooy F. Reporting standards for carotid interventions from the Society for Vascular Surgery. J Vasc Surg. 2011 Jun;53(6):1679-95. doi: 10.1016/j.jvs.2010.11.122. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 3586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No