Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study

NCT07057297 | Recruiting

• 1 other identifier: 108/19-31/2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Arteriosclerosis; Carotid Stenosis; Brain Stroke

Keywords

Carotid Artery; Atherosclerosis; Endarterectomy; Stroke

Outcome Measures

Primary Outcomes (1)

• Restenosis ≥50% at 12 months

  Restenosis ≥50% at 12 months

  12 months

Secondary Outcomes (3)

• Restenosis ≥50%

  30 days

• iCMP/TIA/death/MI

  1 year

• Change in modified Rankin Scale (mRS)

  1 year

Study Arms (1)

Patients after carotid endarterectomy

Included paitnets with sign informed consent after carotid endarterectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo carotid endarterectomy for carotid artery stenosis with primary suture.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• The University Hospital Plzeň: collaborator
• Masaryk Hospital Usti nad Labem: collaborator
• University Hospital Olomouc: collaborator
• County Hospital Liberec, Liberec, Czech Republic: collaborator

Study Sites (1)

Central Military Hospital Prague

Prague, 16200, Czechia

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis; Atherosclerosis; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis

Central Study Contacts

norbert Svoboda, MD

CONTACT

+420973202963; norbert.svoboda@uvn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cpt. MD. Norbert Svoboda, PhD., FEBNS

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2/2027 - 2/2028
• Access Criteria: online

Locations

CZ (1)