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NCT03141580 Clinical Trial

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

Carotid Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03141580
Other study ID # EK-953/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2017
Est. completion date November 1, 2019

Study information
Verified date April 2020
Source University Hospital, Motol
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date November 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)
Examination of the extracranial portion of the internal and common carotid artery with pre-existing stent with NIRS-IVUS.

Locations
Country Name City State
Czechia Motol University Hospital Praha

Sponsors (4)
Lead Sponsor Collaborator
University Hospital, Motol associate professor Petr Hájek, Martin Horváth, professor Josef Veselka

Country where clinical trial is conducted

Czechia, 

References & Publications (12)

Štechovský C, Hájek P, Horváth M, Špacek 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. — View Citation

Štechovský C, Hájek P, Horváth M, Špacek 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. — View Citation

Štechovský C, Hájek P, Horváth 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. — View Citation

Horváth M, Hájek P, Štechovský 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. Review. — View 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. — View 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. Epub 2016 Oct 24. — View 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. — View 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. — View Citation

Veselka J, Špacek M, Hájek P, Horváth M, Štechovský C, Zimolová 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. — View Citation

Veselka J, Špacek M, Horváth M, Štechovský C, Homolová I, Zimolová P, Hájek 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. — View Citation

Veselka J, Cerná D, Zimolová P, Blasko P, Fiedler J, Hájek P, Maly M, Zemánek D, Duchonová R. Thirty-day outcomes of direct carotid artery stenting with cerebral protection in high-risk patients. Circ J. 2007 Sep;71(9):1468-72. — View Citation

Veselka J, Cerná D, Zimolová P, Martinkovicová L, Fiedler J, Hájek P, Malý M, Zemánek D, Duchonová 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 16 months
Secondary 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. 16 months
Secondary 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. 16 months
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