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This prospective, multicenter observational study aims to evaluate the incidence, timing, and characteristics of residual and recurrent (restenosis) carotid artery stenosis following carotid endarterectomy (CEA) with primary closure. Conducted across several neurosurgical centers in the Czech Republic, the study will include patients undergoing elective CEA who meet standard clinical indications.
Participants will undergo preoperative CT angiography and follow-up imaging at 30 days and 1 year post-surgery. Residual stenosis is defined as ≥50% luminal narrowing detected within 30 days postoperatively, while restenosis is evaluated at later time points. The study will also assess clinical outcomes such as ischemic stroke, TIA, myocardial infarction, and mortality. The standardized surgical technique and harmonized diagnostic algorithm across all centers aim to provide robust data on the performance and durability of primary closure CEA.
Full description
Study Objective:
The objective of this study is to assess the true incidence of restenosis following CEA in the Czech Republic. A major advantage of this study is the use of standardized surgical procedures across participating centers, along with unified data collection methods and diagnostic algorithms.
Methodology:
Patient Cohort:
All patients meeting the current guideline indications for CEA will be enrolled.
Exclusion criteria include:
Age ≤18 or ≥90 years
Previous endarterectomy or stenting
Unsuitable vascular anatomy
High perioperative risk
Contralateral cranial nerve X or XII palsy
History of neck irradiation
Tandem carotid stenosis or intracranial vascular pathology (e.g., aneurysm or AVM)
Absence of signed informed consent
Collected data will include:
Epidemiologic risk factors: age, sex, diabetes, hypertension, dyslipidemia, metabolic syndrome, renal insufficiency, smoking, physical activity, weight, comorbidities
Laboratory markers: LDL, HDL, cholesterol, lipoprotein A, triglycerides, CKD-EPI, sedimentation rate, fibrinogen, INR (Quick test), APTT
Diagnostics:
All patients will undergo non-contrast brain CT. Carotid stenosis will be assessed by CT angiography performed within 3 months prior to surgery. In addition to stenosis severity, the degree of calcification will be classified as:
No calcification
Minimal
Partially calcified
Pronounced
Severe/unable to evaluate
Other vascular pathology will also be recorded. Follow-up imaging will be performed at 1 month and 1 year postoperatively. CT findings will be assessed by two independent reviewers.
Surgical Technique:
All patients will receive mono- or dual antiplatelet therapy, and 5,000 IU of heparin will be administered intraoperatively. Surgery may be performed under general anesthesia with electrophysiological monitoring or under local anesthesia, based on the surgeon's preference.
A longitudinal incision will be made anterior to the sternocleidomastoid muscle. The common carotid artery and its branches will be dissected and clamped. The internal carotid artery will be clamped distal to the most significant stenosis, as identified on preoperative CTA. The surgeon will incise through the tunica adventitia and media to expose and excise the atherosclerotic plaque. Any residual fragments will be removed, and the arterial wall will be closed using 6/0 suture.
Follow-Up:
Patients will continue on mono- or dual antiplatelet therapy. Mandatory follow-up CT angiography will be performed at 30 days and1 year. During follow-up, the following will be evaluated:
CTA findings
Overall patient condition
Incidence of ischemic stroke (iCMP), TIA, myocardial infarction, and death
Outcomes:
Primary Outcome:
Restenosis ≥50% at 12 months
Secondary Outcomes:
Residual stenosis ≥50% at 30 days
iCMP/TIA/death/MI
Change in modified Rankin Scale (mRS)
Timeline:
All participating centers (ÚVN, ČB, ÚNL, Poruba, Plzeň, Liberec, Zlín, Olomouc, Hradec Králové, Fifejdy, Ostrava) together treat approximately 600-700 patients annually.
An estimated 350 patients will be enrolled within 6 months. By the end of 2026, 300 patients will be included (expected dropout: 50).
This will allow evaluation of:
Secondary outcomes in all 300 patients
Primary outcome in approximately 8 out of 26 centers (those with complete 12-month data)
Ethical Approval:
All participating centers have received approval from their respective institutional ethics committees.
Funding:
This study is conducted without external financial support.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients without matching any of exclusion criteria who underwent cartotid endarterectomy
Exclusion criteria
Age ≤18 or ≥90 years
Previous endarterectomy or stenting
Unsuitable vascular anatomy
High perioperative risk
Contralateral cranial nerve X or XII palsy
History of neck irradiation
Tandem carotid stenosis or intracranial vascular pathology (e.g., aneurysm or AVM)
Absence of signed informed consent
300 participants in 1 patient group
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Central trial contact
norbert Svoboda, MD
Data sourced from clinicaltrials.gov
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