About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients who undergo carotid endarterectomy for carotid artery stenosis with primary suture.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Restenosis ≥50% at 12 months
Restenosis ≥50% at 12 months
Secondary outcomes
Restenosis ≥50%
Restenosis ≥50%
iCMP/TIA/death/MI
iCMP/TIA/death/MI
Change in modified Rankin Scale (mRS)
Change in modified Rankin Scale (mRS)
Sponsors and contacts
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Charles University, Czech Republic
Lead sponsor
The University Hospital Plzeň
Collaborator
Masaryk Hospital Usti nad Labem
Collaborator
University Hospital Olomouc
Collaborator
County Hospital Liberec, Liberec, Czech Republic
Collaborator