Actively Recruiting
Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
Led by Charles University, Czech Republic · Updated on 2025-07-09
300
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
C
Charles University, Czech Republic
Lead Sponsor
T
The University Hospital Plzeň
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who underwent carotid endarterectomy and do not meet any exclusion criteria
You will not qualify if you...
- Age younger than 18 years or older than 90 years
- Previous carotid endarterectomy or stenting
- Unsuitable vascular anatomy
- High risk for surgery (high perioperative risk)
- Palsy of contralateral cranial nerve X or XII
- History of neck irradiation
- Presence of tandem carotid stenosis or intracranial vascular problems such as aneurysm or arteriovenous malformation
- Not having signed informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Central Military Hospital Prague
Prague, Czechia, 16200
Actively Recruiting
Research Team
N
norbert Svoboda, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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