search
Back to results

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

Primary Purpose

Carotid Atherosclerosis, Carotid Artery Stenting, Atherosclerotic Plaque

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Motol University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Subjects with carotid stent who consented to undergo near-infrared spectroscopy and intravascular ultrasound imaging.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 3, 2017
Last Updated
April 27, 2020
Sponsor
University Hospital, Motol
Collaborators
professor Josef Veselka, associate professor Petr Hájek, Martin Horváth
search

1. Study Identification

Unique Protocol Identification Number
NCT03141580
Brief Title
Long-term Follow-up NIRS-IVUS Imaging of Pre-existing Carotid Stents
Official Title
Long-term Follow-up Near-infrared Spectroscopy and Intravascular Ultrasound Imaging of Internal Carotid Artery Stenosis Treated With Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Motol
Collaborators
professor Josef Veselka, associate professor Petr Hájek, Martin Horváth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis, Carotid Artery Stenting, Atherosclerotic Plaque, Near Infrared Spectroscopy, Restenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Subjects with carotid stent who consented to undergo near-infrared spectroscopy and intravascular ultrasound imaging.
Intervention Type
Diagnostic Test
Intervention Name(s)
Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)
Intervention Description
Examination of the extracranial portion of the internal and common carotid artery with pre-existing stent with NIRS-IVUS.
Primary Outcome Measure Information:
Title
Temporal change of lipid core burden index (LCBI)
Description
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.
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Late lumen change
Description
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.
Time Frame
16 months
Title
Late stent expansion
Description
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.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Motol University Hospital
City
Praha
ZIP/Postal Code
15300
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26044524
Citation
Stechovsky C, Hajek P, Horvath M, Spacek M, Veselka J. Near-infrared spectroscopy combined with intravascular ultrasound in carotid arteries. Int J Cardiovasc Imaging. 2016 Jan;32(1):181-8. doi: 10.1007/s10554-015-0687-x. Epub 2015 Jun 5.
Results Reference
background
PubMed Identifier
26797333
Citation
Stechovsky C, Hajek P, Horvath M, Spacek M, Veselka J. Composition of carotid artery stenosis and restenosis: A series of patients assessed with intravascular ultrasound and near-infrared spectroscopy. Int J Cardiol. 2016 Mar 15;207:64-6. doi: 10.1016/j.ijcard.2016.01.104. Epub 2016 Jan 9. No abstract available.
Results Reference
background
PubMed Identifier
27478475
Citation
Horvath M, Hajek P, Muller JE, Honek J, Stechovsky C, Spacek M, Veselka J. First-in-man near-infrared spectroscopy proof of lipid-core embolization during carotid artery stenting. Arch Med Sci. 2016 Aug 1;12(4):915-8. doi: 10.5114/aoms.2016.60974. Epub 2016 Jul 1. No abstract available.
Results Reference
background
PubMed Identifier
27904523
Citation
Horvath M, Hajek P, Stechovsky C, Honek J, Spacek M, Veselka J. The role of near-infrared spectroscopy in the detection of vulnerable atherosclerotic plaques. Arch Med Sci. 2016 Dec 1;12(6):1308-1316. doi: 10.5114/aoms.2016.62904. Epub 2016 Oct 24.
Results Reference
background
PubMed Identifier
26417188
Citation
Horvath M, Hajek P, Stechovsky C, Honek J, Veselka J. Intravascular Near-Infrared Spectroscopy: A Possible Tool for Optimizing the Management of Carotid Artery Disease. Int J Angiol. 2015 Sep;24(3):198-204. doi: 10.1055/s-0035-1558644. Epub 2015 Aug 6.
Results Reference
background
PubMed Identifier
25127969
Citation
Veselka J, Spacek M, Hajek P, Horvath M, Stechovsky C, Zimolova P. Impact of single versus double vessel carotid disease on long-term survival in patients treated with carotid stenting. Int J Cardiol. 2014 Oct 20;176(3):1299-300. doi: 10.1016/j.ijcard.2014.07.165. Epub 2014 Aug 3. No abstract available.
Results Reference
background
PubMed Identifier
27478456
Citation
Veselka J, Spacek M, Horvath M, Stechovsky C, Homolova I, Zimolova P, Hajek P. Impact of coexisting multivessel coronary artery disease on short-term outcomes and long-term survival of patients treated with carotid stenting. Arch Med Sci. 2016 Aug 1;12(4):760-5. doi: 10.5114/aoms.2016.60964. Epub 2016 Jul 1.
Results Reference
background
PubMed Identifier
22150803
Citation
Spacek M, Zimolova P, Veselka J. Carotid artery stenting without post-dilation. J Interv Cardiol. 2012 Apr;25(2):190-6. doi: 10.1111/j.1540-8183.2011.00694.x. Epub 2011 Dec 8.
Results Reference
background
PubMed Identifier
21542110
Citation
Spacek M, Martinkovicova L, Zimolova P, Veselka J. Mid-term outcomes of carotid artery stenting in patients with angiographic string sign. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):174-9. doi: 10.1002/ccd.23144. Epub 2011 Nov 30.
Results Reference
background
PubMed Identifier
19198010
Citation
Veselka J, Cerna D, Zimolova P, Martinkovicova L, Fiedler J, Hajek P, Maly M, Zemanek D, Duchonova R. Feasibility, safety, and early outcomes of direct carotid artery stent implantation with use of the FilterWire EZ Embolic Protection System. Catheter Cardiovasc Interv. 2009 May 1;73(6):733-8. doi: 10.1002/ccd.21936.
Results Reference
background
PubMed Identifier
17721030
Citation
Veselka J, Cerna D, Zimolova P, Blasko P, Fiedler J, Hajek P, Maly M, Zemanek D, Duchonova R. Thirty-day outcomes of direct carotid artery stenting with cerebral protection in high-risk patients. Circ J. 2007 Sep;71(9):1468-72. doi: 10.1253/circj.71.1468.
Results Reference
background
PubMed Identifier
29957596
Citation
Stechovsky C, Hajek P, Horvath M, Veselka J. Effect of stenting on the near-infrared spectroscopy-derived lipid core burden index of carotid artery plaque. EuroIntervention. 2019 Jun 12;15(3):e289-e296. doi: 10.4244/EIJ-D-17-01054.
Results Reference
background
PubMed Identifier
35070788
Citation
Stechovsky C, Hajek P, Roland R, Horvath M, Veselka J. Long-term changes after carotid stenting assessed by intravascular ultrasound and near-infrared spectroscopy. Cardiovasc Diagn Ther. 2021 Dec;11(6):1180-1189. doi: 10.21037/cdt-21-160.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs