Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study

Recruiting

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

• Registration Number: NCT05864638
• Lead Sponsor: Changhai Hospital

Brief Summary

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

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 Timeline

• Study First Submitted: 2023-04-13
• Study Start: 2023-05-10
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-08-30
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome	90days	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.

Secondary Outcome Measures

Name	Time	Method
Target vessel recanalization rate	at 7 days post-procedure	Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA)
Dichotomized modified Rankin scale (mRS)	90days	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.
NIHSS at 24 hours	24 hours post-procedure	National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome.
NIHSS at 7 days	7 days post procedure	National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.
Reperfusion outcome	Immediately post-procedure	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.
Early successful revascularization rate	During procedure	Early successful revascularization rate of target vessels by bridging therapy

Trial Locations

Locations (1)

Jianimin Liu; 🇨🇳 Shanghai, China