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

NCT ID: NCT06528717

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2024-12-30

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.

Conditions

Carotid Artery Diseases; Stroke; Carotid Atherosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Carotid graft interposition

Intervention Type: PROCEDURE

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.

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.

Carotid graft interposition

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Carotid artery graft replacement; Carotid replacement with Dacron graft

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Cardiovascular Diseases Dedinje

OTHER

Sponsor Role: lead

Responsible Party

Slobodan Pesic

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srdjan Babic, MD PhD

Role: STUDY_DIRECTOR

Institute for Cardiovascular Diseases Dedinje

Locations

Institute for Cardiovascular Diseases Dedinje

Belgrade, , Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Slobodan Pesic, MD

Role: CONTACT

spesic90@gmail.com

00381616303360

Jovan Petrovic, MD

Role: CONTACT

jovanpetrovic1997@gmail.com

Facility Contacts

Slobodan Pesic

Role: primary

spesic90@gmail.com

00381616303360

References

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.

Reference Type: BACKGROUND

PMID: 21609800 (View on PubMed)

Other Identifiers

3586

Identifier Type: -

Identifier Source: org_study_id