RecruitingNCT07057297

Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study


Sponsor

Charles University, Czech Republic

Enrollment

300 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 90 Years

Exclusion Criteria8

  • 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

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Locations(1)

Central Military Hospital Prague

Prague, Czechia

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NCT07057297


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