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NCT Number: NCT05864638

Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study

A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Ischemic Stroke Large Vessel Occlusion Nervous System Diseases Stroke Thrombectomy Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Jianimin Liu

Shanghai, China

Location status: Recruiting

Location contact

Jianimin Liu

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
  • The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Endovascular treatment

Device

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

Primary outcomes

  1. Functional outcome

    Time frame: 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 outcomes

  1. Dichotomized modified Rankin scale (mRS)

    Time frame: 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.

  2. NIHSS at 24 hours

    Time frame: 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.

  3. NIHSS at 7 days

    Time frame: 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.

  4. Reperfusion outcome

    Time frame: 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.

  5. Early successful revascularization rate

    Time frame: During procedure

    Early successful revascularization rate of target vessels by bridging therapy

  6. Target vessel recanalization rate

    Time frame: at 7 days post-procedure

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

Other outcomes

  1. Death

    Time frame: 7 days and 90 days

    All-cause death

  2. Intracerebral hemorrhage(ICH)

    Time frame: 90 days

    Intracranial hemorrhage, including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage

  3. Procedure related complication

    Time frame: within 30 days after procedure

    Procedure related complication

  4. Device related complications

    Time frame: within 30 days after procedure

    Device related complications

  5. adverse events of special interest

    Time frame: within 90 days

    Other adverse events of special interest

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Yang, M.D.

CONTACT

[email protected]

86-21-31161784

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study （OCIN-AIS-EVT REGISTRY）

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 18, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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