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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05550077
Other study ID # OCT-ICAS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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