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NCT07057297Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
30 Jun 2025
Start date
1 Feb 2025
Primary completion date
1 Jan 2026
Lead sponsor
Charles University, Czech Republic
Diseases
Stroke
NCT number
NCT07057297

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Feb 2025 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous endarterectomy or stenting

Other illness

  • History of neck irradiation

Age

  • Age ≤18 or ≥90 years

Other

  • Unsuitable vascular anatomy
  • High perioperative risk
  • Contralateral cranial nerve X or XII palsy
  • Tandem carotid stenosis or intracranial vascular pathology (e.g., aneurysm or AVM)
  • Absence of signed informed consent

Who the study is looking for

  • Patients without matching any of exclusion criteria who underwent cartotid endarterectomy

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Central Military Hospital Prague
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.