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

Not Applicable

Completed

• Conditions: Carotid Atherosclerosis; Carotid Artery Stenting; Near Infrared Spectroscopy; Restenosis; Atherosclerotic Plaque
• Interventions: Diagnostic Test: Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)

• Registration Number: NCT03141580
• Lead Sponsor: University Hospital, Motol

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Study Start: 2017-07-15
• Primary Completion: 2019-09-01
• Study Completion: 2019-11-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)	Subjects with carotid stent who consented to undergo near-infrared spectroscopy and intravascular ultrasound imaging.

Primary Outcome Measures

Name	Time	Method
Temporal change of lipid core burden index (LCBI)	16 months	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.

Secondary Outcome Measures

Name	Time	Method
Late lumen change	16 months	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.
Late stent expansion	16 months	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.

Trial Locations

Locations (1)

Motol University Hospital; 🇨🇿 Praha, Czechia