Residual and recurrent carotid narrowing after endarterectomy with primary closure
Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
The study will test how often and when carotid narrowing comes back after elective carotid endarterectomy with primary closure in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT07057297 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter observational tracking of patients undergoing elective carotid endarterectomy with primary closure at neurosurgical centers in the Czech Republic. Participants undergo preoperative CT angiography and standardized follow-up imaging at 30 days and one year to identify residual stenosis (≥50% within 30 days) and later restenosis. The protocol uses harmonized surgical technique and diagnostic algorithms across sites and collects clinical outcomes such as ischemic stroke, TIA, myocardial infarction, and mortality. Epidemiologic and laboratory risk factors as well as plaque calcification patterns are recorded to characterize predictors of restenosis.
Who should consider this trial
Good fit: Adults meeting guideline indications for elective carotid endarterectomy who can provide informed consent and do not meet exclusion criteria are ideal candidates.
Not a fit: Patients who meet exclusion criteria (age ≤18 or ≥90, prior carotid endarterectomy or stent, unsuitable vascular anatomy, high perioperative risk, contralateral cranial nerve X/XII palsy, prior neck irradiation, tandem lesions or intracranial vascular pathology, or lacking consent) are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the project could give clearer, standardized data on how often narrowing recurs after primary-closure CEA and help refine follow-up and management plans.
How similar studies have performed: Previous observational series have reported variable restenosis rates after CEA, but this coordinated multicenter approach with standardized surgical and imaging protocols is relatively novel in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Prague
- Central Military Hospital Prague — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: norbert Svoboda, MD
- Email: norbert.svoboda@uvn.cz
- Phone: +420973202963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.