Clinical trial NCT03370939: Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke
Official title: Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Artery Occlusion With Infarction (Disorder)
Keywords: ischemic stroke
endovascular treatment
registry
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 2004
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 receiving endovascular treatment.

Brief summary: 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 prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) 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, funded by National Key R\&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.


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);
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 enrollment
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: The end of the procedure
Secondary outcomes:
measure: Recanalization rate at the end of the procedure
timeFrame: at the end of the procedure
measure: Recanalization rate after the first attempt
timeFrame: At baseline, during the procedure, 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
measure: Time from arrival to imaging
timeFrame: At baseline, after taking any brain imaging
measure: Time from imaging to puncture
timeFrame: At baseline, during the procedure, after successful groin puncture
measure: Time from puncture to recanalization
timeFrame: At baseline, during the procedure, after successful recanalization
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun D, Huo X, Raynald, Wang A, Jia B, Tong X, Ma G, Mo D, Gao F, Ma N, Miao Z. Predictors of poor outcome after endovascular treatment for acute vertebrobasilar occlusion: data from ANGEL-ACT registry. Neuroradiology. 2023 Jan;65(1):177-184. doi: 10.1007/s00234-022-03065-x. Epub 2022 Oct 24.
citation: Tong X, Burgin WS, Ren Z, Jia B, Zhang X, Huo X, Luo G, Wang A, Zhang Y, Ma N, Gao F, Song L, Sun X, Liu L, Deng Y, Li X, Wang B, Ma G, Wang Y, Wang Y, Miao Z, Mo D; ANGEL-ACT Study Group. Association of Stroke Subtype With Hemorrhagic Transformation Mediated by Thrombectomy Pass: Data From the ANGEL-ACT Registry. Stroke. 2022 Jun;53(6):1984-1992. doi: 10.1161/STROKEAHA.121.037411. Epub 2022 Mar 31.
citation: Raynald, Sun D, Huo X, Jia B, Tong X, Ma G, Wang A, Mo D, Ma N, Gao F, Amin S, Ren Z, Miao Z; ANGEL-ACT study group. The Safety and Efficacy of Endovascular Treatment in Acute Ischemic Stroke Patients Caused by Large-Vessel Occlusion with Different Etiologies of Stroke: Data from ANGEL-ACT Registry. Neurotherapeutics. 2022 Mar;19(2):501-512. doi: 10.1007/s13311-022-01189-9. Epub 2022 Mar 3.
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citation: Huo X, Sun D, Raynald, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Ma G, Amin S, Ren Z, Miao Z; ANGEL-ACT study group. Endovascular Treatment in Acute Ischemic Stroke with Large Vessel Occlusion According to Different Stroke Subtypes: Data from ANGEL-ACT Registry. Neurol Ther. 2022 Mar;11(1):151-165. doi: 10.1007/s40120-021-00301-z. Epub 2021 Nov 20.
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citation: Tong X, Li S, Liu W, Ren Z, Liu R, Jia B, Zhang X, Huo X, Luo G, Ma G, Wang A, Wang Y, Wang Y, Miao Z, Mo D; ANGEL-ACT study group. Endovascular treatment for acute ischemic stroke in patients with versus without atrial fibrillation: a matched-control study. BMC Neurol. 2021 Sep 29;21(1):377. doi: 10.1186/s12883-021-02386-3.
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