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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)

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

NCT ID

NCT03141580

First Posted

April 3, 2017

Last Updated

April 27, 2020

Sponsor

University Hospital, Motol

Collaborators

professor Josef Veselka, associate professor Petr Hájek, Martin Horváth

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Time Frame

16 months

Secondary Outcome Measure Information:

Title

Late lumen change

Description

Time Frame

16 months

Title

Late stent expansion

Description

Time Frame

16 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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

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