Clinical trial NCT04840719: RECO in the Endovascular Treatment of Acute Ischemic Stroke
Official title: A Prospective ,Multicenter, Registry Study of RECO in the Endovascular Treatment of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Artery Occlusion With Infarction (Disorder)
Keywords: Acute ischemic stroke
endovascular treatment
registry
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke caused by large vessel occlusion and using RECO to receive endovascular treatment.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional independence at 90 days (modified Rankin Scale of 0-2)
timeFrame: [90±7 days after procedure]
measure: Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure
timeFrame: 12-36 hours after the procedure
measure: Time from symptom onset to recanalization
timeFrame: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
Secondary outcomes:
measure: Recanalization rate at the end of the procedure
timeFrame: Immediately after the procedure
measure: Recanalization rate after the first attempt
timeFrame: Immediately after the first attempt of endovascular treatment
measure: Changes in NIHSS score immediately after the procedure
timeFrame: within 2 hours after the procedure
measure: Changes in NIHSS score 24 hours after the procedure
timeFrame: 24 hours after the procedure
measure: Changes in NIHSS score 7 days after the procedure or at discharge
timeFrame: 7 days after the procedure or discharge
measure: EQ-5D 90 days after the procedure
timeFrame: 90±7 days after the procedure
measure: Barthel index (BI) 90 days after the procedure
timeFrame: 90±7 days after the procedure
measure: Parenchymal hematoma (PH2)
timeFrame: 12-36 hours after the procedure
measure: Any intracranial hemorrhage on imaging
timeFrame: 12-36 hours after the procedure
measure: All-cause mortality within 90 days
timeFrame: 90±7 days after the procedure
measure: Time from onset to arrival
timeFrame: At baseline, after arrival at the hospital immediately
measure: Time from arrival to imaging
timeFrame: At baseline, after taking any brain imaging immediately
measure: Time from imaging to puncture
timeFrame: At baseline, during the procedure, after successful groin puncture immediately
measure: Time from puncture to recanalization
timeFrame: At baseline, during the procedure, after successful recanalization immediately
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University, Beijing Tiantan Hospital
name: Zhongrong Miao, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: