Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-15

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intracranial Atherosclerosis Optical Coherence Tomography Plaque, Atherosclerotic Artery Stenosis Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Optical Coherence Tomography (OCT)

OCT and other classical imaging evaluation such as Transcranial Color Doppler (TCCD) and High resolution-MRI will be performed. The tailored treatment (such as anti-thrombotic management, post-dilation, et al) will be considered when specific plaque characteristics (including but not limited to in situ thrombus formation, macrocacilfication, et al), were observed under OCT.

Optical Coherence Tomography

Intervention Type DIAGNOSTIC_TEST

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

Percutaneous transluminal angioplasty and stenting

Intervention Type PROCEDURE

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

Non-Optical Coherence Tomography (N-OCT)

Classical imaging evaluation such as TCCD and High resolution-MRI will be performed, followed by standard percutaneous transluminal angioplasty and stenting.

Percutaneous transluminal angioplasty and stenting

Intervention Type PROCEDURE

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

Interventions

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Optical Coherence Tomography

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

Intervention Type DIAGNOSTIC_TEST

Percutaneous transluminal angioplasty and stenting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)