Long-term Follow-up NIRS-IVUS Imaging of Pre-existing Carotid Stents

Study Overview
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Brief Summary
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The 'Long-term Follow-up Near-infrared Spectroscopy and Intravascular Ultrasound Imaging of Internal Carotid Artery Stenosis Treated With Stenting' trial is an academic research project. It follows already published results of a research on carotid plaque composition in patients undergoing carotid stenting. Patients who were treated with carotid stenting will be invited to participate on the trial. The written informed consent will be needed. The participants will undergo carotid angiography, intravascular near-infrared spectroscopy and intravascular ultrasound of the extracranial portion of the internal and common carotid artery with implanted stent. The aim of the trial is to describe long-term change of the luminal and stent dimensions, vessel wall remodeling and plaque composition after carotid stenting. The findings will help to understand the long-term effect of carotid stenting on the carotid stenosis and mechanisms of plaque stabilization - sealing with stent.

Official Title
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Long-term Follow-up Near-infrared Spectroscopy and Intravascular Ultrasound Imaging of Internal Carotid Artery Stenosis Treated With Stenting

Conditions
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Carotid Artery Stenting, Restenosis, Carotid Atherosclerosis, Atherosclerotic Plaque, Near Infrared Spectroscopy

Intervention / Treatment
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* Diagnostic Test: Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previous carotid stenting data from periprocedural NIRS-IVUS available written informed consent Exclusion Criteria: occlusion of the carotid artery on the side of the implanted stent indication for carotid intervention on the side of the implanted stent high procedural risk (difficult anatomy, risk of puncture site bleeding)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Subjects with carotid stent who consented to undergo near-infrared spectroscopy and intravascular ultrasound imaging. | Diagnostic Test: Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)<br>* Examination of the extracranial portion of the internal and common carotid artery with pre-existing stent with NIRS-IVUS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal change of lipid core burden index (LCBI) | Difference between LCBI (a dimensionless number) within the segment of the carotid artery with implanted stent in the time point of the carotid stenting (baseline LCBI) and in the time point of study intervention (follow-up LCBI). Data from NIRS. | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen change | Difference between luminal volume (mm3) within the segment of the carotid artery with implanted stent in the time point of the carotid stenting (baseline lumen volume) and in the time point of study intervention (follow-up lumen volume). Data from IVUS. | 16 months | 
| Late stent expansion | Difference between stent volume (mm3) within the segment of the carotid artery with implanted stent in the time point of the carotid stenting (baseline stent volume) and in the time point of study intervention (follow-up stent volume). Data from IVUS. | 16 months |