A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke

Oriental Collaboration Group on Emerging Advanced Therapy for Neurovascular Diseases Consortium-Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study (OCEAN-AIS-EVT REGISTRY)

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

Study Overview

• Status: Recruiting
• Conditions: Thrombosis; Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Pengfei Yang, M.D.; Phone Number: 86-21-31161784; Email: 15921196312@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Jianimin Liu
    • Contact: Jianimin Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All acute ischemic stroke patients receiving endovascular treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause death	7 days and 90 days
Intracerebral hemorrhage(ICH)	symptomatic ICH, asymptomatic ICH. The Heidelberg bleeding classification categorizes intracranial hemorrhages occurring after ischemic stroke and reperfusion therapy.	90 days
Procedure related complication	Procedure related complication	within 30 days after procedure
adverse event (special concern)	adverse event (special concern)	within 30 days after procedure
Device related complications	Device related complications	within 30 days after procedure

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jianimin Liu, M.D., Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Thrombosis; Cerebral Infarction
• Other Study ID Numbers: OCEAN-AIS-EVT REGISTRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.; Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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