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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCharles University, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Patients after carotid endarterectomy

Trial outcomes

Primary outcomes

1

Restenosis ≥50% at 12 months

Restenosis ≥50% at 12 months

Time frame
12 months

Secondary outcomes

1

Restenosis ≥50%

Restenosis ≥50%

Time frame
30 days
2

iCMP/TIA/death/MI

iCMP/TIA/death/MI

Time frame
1 year
3

Change in modified Rankin Scale (mRS)

Change in modified Rankin Scale (mRS)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

The University Hospital Plzeň

Collaborator

Masaryk Hospital Usti nad Labem

Collaborator

University Hospital Olomouc

Collaborator

County Hospital Liberec, Liberec, Czech Republic

Collaborator