Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis (OCT-ICAS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Plaque, Atherosclerotic; Intracranial Atherosclerosis; Artery Stenosis; Optical Coherence Tomography
• Intervention / Treatment: Diagnostic test: Optical Coherence Tomography; Procedure: Percutaneous transluminal angioplasty and stenting

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Liqun Jiao, Professor; Phone Number: +8613911224991; Email: liqunjiao@sina.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Ran Xu, MD; Phone Number: +8615001376121; Email: xrqssq@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults (aged over 18) with symptomatic ICAS (≥ 50%) will be enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	Procedure: Percutaneous transluminal angioplasty and stenting; Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcomes: short-term death or stroke	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.	30 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or stroke	(long term; more than three months)	1 year after enrollment
Ipsilateral stroke	(same territory as the index stenosis)	1 year after enrollment
Type of recurrent event	(TIA, ischaemic stroke, haemorrhagic stroke)	1 year after enrollment
Death	(long term; more than three months)	1 year after enrollment
Restenosis	(≥ 50%) of the involved vessel documented by conventional cerebral angiography	1 year after enrollment
Dependency	Modified Rankin Scale or equivalent	1 year after enrollment

Collaborators and Investigators

• Sponsor: jiaoliqun

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Intravascular Imaging; Intracranial Atherosclerotic Stenosis; Percutaneous Transluminal Angioplasty and Stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Constriction, Pathologic; Atherosclerosis; Plaque, Atherosclerotic; Intracranial Arteriosclerosis
• Other Study ID Numbers: OCT-ICAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No