Actively Recruiting
Tracking Residual and Recurring Carotid Artery Narrowing After Carotid Endarterectomy With Primary Closure in Adults
Led by Charles University, Czech Republic · Updated on 2025-07-09
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Research Team
N
norbert Svoboda, MD
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