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Carotid AtherosclerosisNCT03141580

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

A study testing Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS) in people with Carotid Atherosclerosis and Carotid Artery Stenting, run by University Hospital, Motol at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteCzechia
Study dates
15 Jul 2017to 1 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • previous carotid stenting
  • data from periprocedural NIRS-IVUS available
  • written informed consent

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Motol University Hospital

    Prague, 15300

Other trials in Czechia

About this study

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

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.

Being tested
Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)
Medical subject headings
Carotid Artery Diseases, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03141580
Study groupRoleWhat they receive
Study groupExperimentalSubjects with carotid stent who consented to undergo near-infrared spectroscopy and intravascular ultrasound imaging.
Receives: Diagnostic Test: Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 months

Secondary outcomes (2)

  1. 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.

    Measured: 16 months

  2. 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.

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start15 Jul 2017
  3. Primary completion1 Sep 2019
  4. Study completion1 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03141580
Sponsor's protocol ID
EK-953/16
Status last verified
Apr 2020
First submitted
3 Apr 2017
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26044524

  • 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.

    PubMed 26797333

  • 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.

    PubMed 27478475

  • 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.

    PubMed 27904523

  • 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.

    PubMed 26417188

  • 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.

    PubMed 25127969

  • 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.

    PubMed 27478456

  • 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.

    PubMed 22150803

  • 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.

    PubMed 21542110

  • 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.

    PubMed 19198010

  • 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.

    PubMed 17721030

  • 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.

    PubMed 29957596

  • 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.

    PubMed 35070788

Questions about this trial

What is this clinical trial studying?

A study testing Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS) in people with Carotid Atherosclerosis and Carotid Artery Stenting, run by University Hospital, Motol at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporal change of lipid core burden index (LCBI) (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03141580, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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