Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study

Changhai Hospital10,000 enrolled

Overview

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

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

10,000

Conditions

Acute Ischemic Stroke Large Vessel Occlusion Thrombectomy Thrombosis

Interventions

Endovascular treatmentDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Jianimin Liu

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 90days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Immediately post-procedure

Early successful revascularization rate

Early successful revascularization rate of target vessels by bridging therapy

Time frame: During procedure

Target vessel recanalization rate

Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA)

Central Contacts

Pengfei Yang, M.D.

CONTACT

86-21-31161784 15921196312@163.com

Data from ClinicalTrials.gov

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