Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

Ischemic Stroke Clinical Trial

— OCT-ICAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550077
• Other study ID #: OCT-ICAS
• Status: Recruiting
• Start date: March 15, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Liqun Jiao, Professor
• Phone: +8613911224991
• Email: liqunjiao[@]sina.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Stenosis
• Atherosclerosis
• Constriction, Pathologic
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Optical Coherence Tomography
• Plaque, Atherosclerotic

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
jiaoliqun

Country where clinical trial is conducted

China, 

Outcome

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