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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05864638
Other study ID # OCEAN-AIS-EVT REGISTRY
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date August 31, 2028

Study information

Verified date August 2023
Source Changhai Hospital
Contact Pengfei Yang, M.D.
Phone 86-21-31161784
Email 15921196312@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.


Description:

The OCEAN-AIS-EVT-Registry is a multicenter, observational, registry study, and aims to assess the safety and outcome of endovascular treatment for acute ischemic stroke in real clinical practice. The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±14 days).


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date August 31, 2028
Est. primary completion date August 30, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of AIS with anterior or posterior circulation LVO confirmed by CTA, MRA or DSA; - To receive endovascular treatment; - Agree to participate in the study and signed informed consent form. Exclusion Criteria: - This study does not set exclusion criteria

Study Design


Locations

Country Name City State
China Jianimin Liu Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Death All-cause death 7 days and 90 days
Other Intracerebral hemorrhage(ICH) symptomatic ICH, asymptomatic ICH. The Heidelberg bleeding classification categorizes intracranial hemorrhages occurring after ischemic stroke and reperfusion therapy. 90 days
Other Procedure related complication Procedure related complication within 30 days after procedure
Other adverse event (special concern) adverse event (special concern) within 30 days after procedure
Other Device related complications Device related complications within 30 days after procedure
Primary Functional outcome Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome. 90days
Secondary Dichotomized modified Rankin scale (mRS) Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome. 90days
Secondary NIHSS at 24 hours Change in stroke severity (NIHSS score) at 24 hours post treatment. The value range 0-42: higher scores mean a worse outcome. 24 hours post treatment
Secondary NIHSS at 7 days Change in stroke severity (NIHSS score) at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome. 7 days post procedure
Secondary Reperfusion outcome Reperfusion outcome (eTICI 2b or greater) in final angiogram. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome. Immediately post-procedure
Secondary Reperfusion outcome Reperfusion outcome (eTICI 2b or greater) at 7 days post procedure. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome. 7 days post procedure
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