Artery Stenosis, Intracranial Atherosclerosis, Ischemic Stroke, Optical Coherence Tomography, Plaque, Atherosclerotic
Conditions
Keywords
Optical Coherence Tomography, Intravascular Imaging, Intracranial Atherosclerotic Stenosis, Percutaneous Transluminal Angioplasty and Stenting
Brief summary
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_TESTOptical Coherence Tomography
Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography
Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.
Sponsors
jiaoliqun
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes: short-term death or stroke | 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
| Measure | Time frame | Description |
|---|---|---|
| Type of recurrent event | 1 year after enrollment | (TIA, ischaemic stroke, haemorrhagic stroke) |
| Death or stroke | 1 year after enrollment | (long term; more than three months) |
| Death | 1 year after enrollment | (long term; more than three months) |
| Restenosis | 1 year after enrollment | (≥ 50%) of the involved vessel documented by conventional cerebral angiography |
| Dependency | 1 year after enrollment | Modified Rankin Scale or equivalent |
| Ipsilateral stroke | 1 year after enrollment | (same territory as the index stenosis) |
Countries
China
Contacts
Primary ContactLiqun Jiao, Professor
Outcome results
None listed