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Completed

NCT Number: NCT03141580

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

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.

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Key information

Conditions

Carotid Atherosclerosis Atherosclerotic Plaque Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Artery Stenting Central Nervous System Diseases Cerebrovascular Disorders Near Infrared Spectroscopy Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Restenosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motol University Hospital

Prague, 15300, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Temporal change of lipid core burden index (LCBI)

    Time frame: 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 outcomes

  1. Late lumen change

    Time frame: 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.

  2. Late stent expansion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Collaborators

  • Martin Horváth
  • associate professor Petr Hájek
  • professor Josef Veselka

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 5, 2017
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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