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
52 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
Researchers are evaluating the occurrence and characteristics of residual and recurrent carotid artery narrowing (stenosis) after carotid endarterectomy (CEA) with primary closure. This observational study is conducted across multiple neurosurgical centers in the Czech Republic and focuses on patients undergoing elective CEA following standard clinical guidelines. The study aims to provide reliable data on the performance and durability of primary closure CEA using standardized surgical techniques and diagnostic methods. Participants will receive preoperative CT angiography and follow-up imaging at 30 days and 1 year after surgery. The surgical procedure involves plaque removal from the carotid artery, with patients receiving mono- or dual antiplatelet therapy and intraoperative heparin. Surgery may be performed under general or local anesthesia with electrophysiological monitoring. Follow-up includes mandatory CT angiography at 30 days and 1 year, assessing residual stenosis at 30 days and restenosis at 12 months, along with clinical outcomes such as ischemic stroke, transient ischemic attack, myocardial infarction, and death. During the study, participants will undergo brain CT scans, blood tests, and detailed evaluation of vascular condition before surgery. Follow-up assessments will include imaging reviews by independent experts, clinical status checks, and monitoring for adverse events or neurological changes. The primary outcome measured is restenosis of 50% or greater at 12 months, with secondary outcomes including residual stenosis at 30 days and changes in neurological function. The study expects to enroll about 350 patients over 6 months, with follow-up continuing through 1 year post-surgery.
CONDITIONS
Brief 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 without meeting any exclusion criteria
- Signed informed consent provided
You will not qualify if you...
- Age under 18 or over 90 years
- Previous carotid 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 such as aneurysm or arteriovenous malformation
- Absence of signed informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo carotid endarterectomy surgery with primary closure and receive intraoperative care including antiplatelet therapy and heparin administration.
1 surgery visit
Duration - 1 year
Participants receive follow-up CT angiography and clinical assessments to evaluate residual stenosis and overall health status.
1 visit at 1 month and 1 visit at 1 year (in-person)
Trial Site Locations
Total: 1 location
1
Central Military Hospital Prague
Prague, Czechia, 16200
Actively Recruiting
Research Team
N
norbert Svoboda, MD
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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