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

NCT ID: NCT07057297

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-01-01

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.

Detailed Description

Study Objective:

The objective of this study is to assess the true incidence of restenosis following CEA in the Czech Republic. A major advantage of this study is the use of standardized surgical procedures across participating centers, along with unified data collection methods and diagnostic algorithms.

Methodology:

Patient Cohort:

All patients meeting the current guideline indications for CEA will be enrolled.

Exclusion criteria include:

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

Collected data will include:

Epidemiologic risk factors: age, sex, diabetes, hypertension, dyslipidemia, metabolic syndrome, renal insufficiency, smoking, physical activity, weight, comorbidities

Laboratory markers: LDL, HDL, cholesterol, lipoprotein A, triglycerides, CKD-EPI, sedimentation rate, fibrinogen, INR (Quick test), APTT

Diagnostics:

All patients will undergo non-contrast brain CT. Carotid stenosis will be assessed by CT angiography performed within 3 months prior to surgery. In addition to stenosis severity, the degree of calcification will be classified as:

No calcification

Minimal

Partially calcified

Pronounced

Severe/unable to evaluate

Other vascular pathology will also be recorded. Follow-up imaging will be performed at 1 month and 1 year postoperatively. CT findings will be assessed by two independent reviewers.

Surgical Technique:

All patients will receive mono- or dual antiplatelet therapy, and 5,000 IU of heparin will be administered intraoperatively. Surgery may be performed under general anesthesia with electrophysiological monitoring or under local anesthesia, based on the surgeon's preference.

A longitudinal incision will be made anterior to the sternocleidomastoid muscle. The common carotid artery and its branches will be dissected and clamped. The internal carotid artery will be clamped distal to the most significant stenosis, as identified on preoperative CTA. The surgeon will incise through the tunica adventitia and media to expose and excise the atherosclerotic plaque. Any residual fragments will be removed, and the arterial wall will be closed using 6/0 suture.

Follow-Up:

Patients will continue on mono- or dual antiplatelet therapy. Mandatory follow-up CT angiography will be performed at 30 days and1 year. During follow-up, the following will be evaluated:

CTA findings

Overall patient condition

Incidence of ischemic stroke (iCMP), TIA, myocardial infarction, and death

Outcomes:

Primary Outcome:

Restenosis ≥50% at 12 months

Secondary Outcomes:

Residual stenosis ≥50% at 30 days

iCMP/TIA/death/MI

Change in modified Rankin Scale (mRS)

Timeline:

All participating centers (ÚVN, ČB, ÚNL, Poruba, Plzeň, Liberec, Zlín, Olomouc, Hradec Králové, Fifejdy, Ostrava) together treat approximately 600-700 patients annually.

An estimated 350 patients will be enrolled within 6 months. By the end of 2026, 300 patients will be included (expected dropout: 50).

This will allow evaluation of:

Secondary outcomes in all 300 patients

Primary outcome in approximately 8 out of 26 centers (those with complete 12-month data)

Ethical Approval:

All participating centers have received approval from their respective institutional ethics committees.

Funding:

This study is conducted without external financial support.

Conditions

Carotid Arteriosclerosis; Carotid Stenosis; Brain Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients after carotid endarterectomy

Included paitnets with sign informed consent after carotid endarterectomy

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University Hospital Plzeň

UNKNOWN

Sponsor Role: collaborator

Masaryk Hospital Usti nad Labem

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

County Hospital Liberec, Liberec, Czech Republic

UNKNOWN

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Norbert Svoboda

cpt. MD. Norbert Svoboda, PhD., FEBNS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Central Military Hospital Prague

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

norbert Svoboda, MD

Role: CONTACT

norbert.svoboda@uvn.cz

+420973202963

Facility Contacts

Norbert Svoboda, MD

Role: primary

norbert.svoboda@uvn.cz

+420973202963

David Netuka, Prof.

Role: backup

david.netuka@uvn.cz

++420973202963

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

108/19-31/2024

Identifier Type: -

Identifier Source: org_study_id