NCT07057297 Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
| NCT ID | NCT07057297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charles University, Czech Republic |
| Condition | Carotid Arteriosclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-02-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07057297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Carotid Arteriosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07057297 currently recruiting?
Yes, NCT07057297 is actively recruiting participants. Contact the research team at norbert.svoboda@uvn.cz for enrollment information.
Where is the NCT07057297 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT07057297 clinical trial?
NCT07057297 is sponsored by Charles University, Czech Republic. The trial plans to enroll 300 participants.