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

NCT06528717 | Recruiting

• 1 other identifier: 3586
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Artery Diseases; Stroke; Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• restenosis rate

  through study completion, an average of 2 years

• graft patency

  through study completion, an average of 2 years

• patient survival

  through study completion, an average of 2 years

Study Arms (2)

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

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

Interventions

Carotid graft interposition 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.

Also known as: Carotid artery graft replacement, Carotid replacement with Dacron graft

ECA flow preserved group; Ligated ECA group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Cardiovascular Diseases Dedinje: lead

Study Sites (1)

Institute for Cardiovascular Diseases Dedinje

Belgrade, 11000, Serbia

RECRUITING

Related Publications (1)

• 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.

  PMID: 21609800 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Srdjan Babic, MD PhD

  Institute for Cardiovascular Diseases Dedinje

  STUDY DIRECTOR

Central Study Contacts

Slobodan Pesic, MD

CONTACT

00381616303360; spesic90@gmail.com

Jovan Petrovic, MD

CONTACT

jovanpetrovic1997@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 30, 2024
• Study Start: June 12, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)