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Recruiting NCT05550077

Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

— Observational Intracranial Atherosclerosis Optical Coherence Tomography Plaque, Atherosclerotic Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical Coherence Tomography, Percutaneous transluminal angioplasty and stenting.
Who it may be relevant to
Registry conditions: Intracranial Atherosclerosis, Optical Coherence Tomography, Plaque, Atherosclerotic, Artery Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis: a Prospective Registry Study (OCT-ICAS)

Overview

To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).

Detailed description

Stroke was the second leading cause of death worldwide and the leading cause of death in China in 2017. ICAS accounted for 10% to 15% of ischemic stroke in Western countries, and as much as 46.6%in Asia in 2009.

For patients with ICAS, the risk of stroke is highly related to the histopathology of atheromatous plaques. Therefore, characterizing the morphology and composition of plaques in ICAS may help to predict the risk of stroke occurrence and allow the adoption of preventive or therapeutic management to prevent such life-threatening events. OCT, with a resolution of 10μm, may provide more reliable information in characterizing atheromatous plagues.

This study aims to get a better insight into the value of OCT in evaluating the vessel wall structure and therefore guiding the interventional therapy of ICAS. In addition, the clinical and biological information will be included to achieve correlation analysis so as to get biomarkers subject to various plaque characteristics.

Interventions

  • Diagnostic test Optical Coherence Tomography
    Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography
  • Procedure Percutaneous transluminal angioplasty and stenting
    Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.

Primary outcome measures

  • Safety outcomes: short-term death or stroke [Time frame: 30 days after enrollment]
Secondary outcome measures (6)
  • Death or stroke [Time frame: 1 year after enrollment]
  • Ipsilateral stroke [Time frame: 1 year after enrollment]
  • Type of recurrent event [Time frame: 1 year after enrollment]
  • Death [Time frame: 1 year after enrollment]
  • Restenosis [Time frame: 1 year after enrollment]
  • Dependency [Time frame: 1 year after enrollment]

Eligibility criteria

Inclusion criteria

  • Symptomatic ICAS. Participants with ICAS with a transient ischaemic attack (TIA) or stroke attributable to the territory of the stenotic artery were defined as symptomatic. A TIA was defined as a transient episode of neurological dysfunction (focal weakness or language disturbance, transient monocular blindness, or required assistance in walking) caused by focal brain or retinal ischaemia that lasted for at least 10 minutes but resolved within 24 hours
  • Stenotic degree ≥ 50%, measured by digital subtraction angiography
  • The stenosis must located in at least one major intracranial artery (internal carotid artery, vertebral artery, middle cerebral artery, or basilar artery)

Exclusion criteria

  • Arteriovenous Malformation
  • Aneurysm

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xuanwu Hospital, Capital Medical University — Beijing

Publications

  • Li T, Xu R, Ma Y, Wang T, Yang B, Jiao L. Calcification is a risk factor for intracranial in-stent restenosis: an optical coherence tomography study. J Neurointerv Surg. 2024 Aug 14;16(9):897-901. doi: 10.1136/jnis-2023-020624. PMID 37536931

Identifiers

NCT: NCT05550077 · OCT-ICAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗