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NCT Number: NCT05550077

Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography

Diagnostic Test

Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography

Percutaneous transluminal angioplasty and stenting

Procedure

Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.

Primary outcomes

  1. Safety outcomes: short-term death or stroke

    Time frame: 30 days after enrollment

    We defined 'short-term' as the periprocedural period, or mean follow-up time less than or equal to three months after enrollment. Stroke was identified in the vascular territory of the stenosed vessel, either ischaemic or haemorrhagic. We defined death or stroke as a composite of death of any cause or non-fatal stroke of any type in any territory.

Secondary outcomes

  1. Death or stroke

    Time frame: 1 year after enrollment

    (long term; more than three months)

  2. Ipsilateral stroke

    Time frame: 1 year after enrollment

    (same territory as the index stenosis)

  3. Type of recurrent event

    Time frame: 1 year after enrollment

    (TIA, ischaemic stroke, haemorrhagic stroke)

  4. Death

    Time frame: 1 year after enrollment

    (long term; more than three months)

  5. Restenosis

    Time frame: 1 year after enrollment

    (≥ 50%) of the involved vessel documented by conventional cerebral angiography

  6. Dependency

    Time frame: 1 year after enrollment

    Modified Rankin Scale or equivalent

Study contacts

Contact information is provided by the study sponsor or research team.

Liqun Jiao, Professor

CONTACT

[email protected]

+8613911224991

Sponsors and collaborators

Lead sponsor

jiaoliqun

Other

Registry information

Official study title

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

Acronym: OCT-ICAS

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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