Actively Recruiting

Age: 18Years - 90Years
All Genders
ID07057297

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent carotid endarterectomy without meeting any exclusion criteria
  • Signed informed consent provided
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Loading map...

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

Similar Trials

An Exploratory Study of [18F]AlF-NOTA-octreotide PET/MRI in ...

Stroke (CVA) or TIA

Actively Recruiting

1 location

Carotid Artery Stenting During Endovascular Treatment of Acu...

Stroke, Acute

Actively Recruiting

1 location

Carotid Atherosclerosis: Evaluating Imaging Biomarkers to Pr...

Carotid Stenosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here