Skip to main content
Clinical Trials/NCT03141580
NCT03141580
Completed
Not Applicable

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

University Hospital, Motol1 site in 1 country52 target enrollmentJuly 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Atherosclerosis
Sponsor
University Hospital, Motol
Enrollment
52
Locations
1
Primary Endpoint
Temporal change of lipid core burden index (LCBI)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2017
End Date
November 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Motol
Responsible Party
Principal Investigator
Principal Investigator

Cyril štěchovský

Principal Investigator

University Hospital, Motol

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Late lumen change(16 months)
  • Late stent expansion(16 months)

Study Sites (1)

Loading locations...

Similar Trials