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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03141580

Enrollment

Registered

2017-05-05

Start date

2017-07-15

Completion date

2019-11-01

Last updated

2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTNear-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)

Examination of the extracranial portion of the internal and common carotid artery with pre-existing stent with NIRS-IVUS.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026