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

University Hospital, Motol

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03141580

EK-953/16

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Study group

Experimental group

Description:

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

Treatment:

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