Ischemic Stroke Clinical Trial
— OCT-ICASOfficial title:
Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis: a Prospective Registry Study (OCT-ICAS)
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 |
To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).
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 |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
jiaoliqun |
China,
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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