Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

Recruiting

• Conditions: Intracranial Atherosclerosis; Optical Coherence Tomography; Plaque, Atherosclerotic; Artery Stenosis; Ischemic Stroke
• Interventions: Procedure: Percutaneous transluminal angioplasty and stenting; Diagnostic Test: Optical Coherence Tomography

• Registration Number: NCT05550077
• Lead Sponsor: jiaoliqun

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.

Study Timeline

• Study Start: 2020-03-15
• Status Verified: 2022-09
• Study First Submitted: 2022-09-18
• Study First Submitted QC: 2022-09-18
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-23
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Optical Coherence Tomography (N-OCT)	Percutaneous transluminal angioplasty and stenting	Classical imaging evaluation such as TCCD and High resolution-MRI will be performed, followed by standard percutaneous transluminal angioplasty and stenting.
Optical Coherence Tomography (OCT)	Optical Coherence Tomography	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 (OCT)	Percutaneous transluminal angioplasty and stenting	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Ipsilateral stroke	1 year after enrollment	(same territory as the index stenosis)
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)
Dependency	1 year after enrollment	Modified Rankin Scale or equivalent

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China