RECO in the Endovascular Treatment of Acute Ischemic Stroke

Beijing Tiantan Hospital1,000 enrolled

Overview

Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Intracranial Artery Occlusion With Infarction (Disorder)

Interventions

RECODEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years old 2. Diagnosis of acute ischemic stroke 3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6 4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting 5. The patient or the patient's legal representative is able and willing to sign the informed consent Exclusion Criteria: 1. Isolated cervical ICA or VA occlusion; 2. No evidence of LVO on DSA.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Functional independence at 90 days (modified Rankin Scale of 0-2)

The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.

Time frame: [90±7 days after procedure]

Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure

Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration

Time frame: 12-36 hours after the procedure

Time from symptom onset to recanalization

Minutes

Time frame: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours

Secondary Outcomes

Recanalization rate at the end of the procedure

modified thrombolysis in cerebral infarction (mTICI) 2b-3

Time frame: Immediately after the procedure

Recanalization rate after the first attempt

mTICI score 2b-3

Time frame: Immediately after the first attempt of endovascular treatment

Changes in NIHSS score immediately after the procedure

difference between NIHSS score immediately after the procedure and baseline

Time frame: within 2 hours after the procedure

Central Contacts

Baixue Jia, PhD,MD

CONTACT

86-010-67098857 beckyberry@163.com

Data from ClinicalTrials.gov

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