Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study

Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study （OCIN-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
• Intervention / Treatment: Device: Endovascular treatment

Detailed Description

The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.

The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).

• Study Type: Observational
• Enrollment (Estimated): 10000

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:

1. Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
2. Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
3. The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.

Exclusion Criteria:

1) No exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular treatment	Device: Endovascular treatment; Endovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis

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	National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome.	24 hours post-procedure
NIHSS at 7 days	National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.	7 days post procedure
Reperfusion outcome	Immediate target vessel recanalization rate post-procedure: defined as proportion of subjects with extended thrombolysis in cerebral infarction (eTICI) score is 2b to 3 The value range 0-3: higher scores mean a better outcome.	Immediately post-procedure
Early successful revascularization rate	Early successful revascularization rate of target vessels by bridging therapy	During procedure
Target vessel recanalization rate	Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA)	at 7 days post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause death	7 days and 90 days
Procedure related complication	Procedure related complication	within 30 days after procedure
Device related complications	Device related complications	within 30 days after procedure
Intracerebral hemorrhage(ICH)	Intracranial hemorrhage, including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage	90 days
adverse events of special interest	Other adverse events of special interest	within 90 days

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Embolism and Thrombosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia; Thrombosis
• Other Study ID Numbers: OCIN-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
• product manufactured in and exported from the U.S.: No