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

NCT03141580 | Completed

• 1 other identifier: EK-953/16
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Atherosclerosis; Carotid Artery Stenting; Atherosclerotic Plaque; Near Infrared Spectroscopy; Restenosis

Outcome Measures

Primary Outcomes (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.

  16 months

Secondary Outcomes (2)

• Late lumen change

  16 months

• Late stent expansion

  16 months

Study Arms (1)

Study group

EXPERIMENTAL

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

Diagnostic Test: Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)

Interventions

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 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Motol: lead
• professor Josef Veselka: collaborator
• associate professor Petr Hájek: collaborator
• Martin Horváth: collaborator

Study Sites (1)

Motol University Hospital

Prague, 15300, Czechia

Location

Related Publications (13)

• 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.

  PMID: 26044524 BACKGROUND

• 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.

  PMID: 26797333 BACKGROUND

• 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.

  PMID: 27478475 BACKGROUND

• 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.

  PMID: 27904523 BACKGROUND

• 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.

  PMID: 26417188 BACKGROUND

• 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.

  PMID: 25127969 BACKGROUND

• 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.

  PMID: 27478456 BACKGROUND

• 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.

  PMID: 22150803 BACKGROUND

• 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.

  PMID: 21542110 BACKGROUND

• 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.

  PMID: 19198010 BACKGROUND

• 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.

  PMID: 17721030 BACKGROUND

• 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.

  PMID: 29957596 BACKGROUND

• 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.

  PMID: 35070788 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Plaque, Atherosclerotic

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 5, 2017
• Study Start: July 15, 2017
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)