Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT)

Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Artery Occlusion With Infarction (Disorder)

• Study Type: Observational
• Enrollment (Actual): 2004

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke caused by large vessel occlusion and receiving endovascular treatment.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90±7 days after enrollment
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	12-36 hours after the procedure
Time from symptom onset to recanalization		The end of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recanalization rate at the end of the procedure	mTICI score 2b-3	at the end of the procedure
Recanalization rate after the first attempt	mTICI score 2b-3	At baseline, during the procedure, 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	within 2 hours after the procedure
Changes in NIHSS score 24 hours after the procedure	difference between NIHSS score 24 hours after the procedure and baseline	24 hours after the procedure
Changes in NIHSS score 7 days after the procedure or at discharge	difference between NIHSS score 7 days after the procedure or discharge and baseline	7 days after the procedure or discharge
EQ-5D 90 days after the procedure	EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome.	90±7 days after the procedure
Barthel index (BI) 90 days after the procedure	The BI has a score of 0-100. A higher score indicates a better outcome.	90±7 days after the procedure
Parenchymal hematoma (PH2)	PH2 is defined as hematoma in >30% of infarct area	12-36 hours after the procedure
Any intracranial hemorrhage on imaging		12-36 hours after the procedure
All-cause mortality within 90 days		90±7 days after the procedure
Time from onset to arrival		At baseline, after arrival at the hospital
Time from arrival to imaging		At baseline, after taking any brain imaging
Time from imaging to puncture		At baseline, during the procedure, after successful groin puncture
Time from puncture to recanalization		At baseline, during the procedure, after successful recanalization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Zhongrong Miao, PhD, Capital Medical University, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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. 2022 Oct 24. doi: 10.1007/s00234-022-03065-x. [Epub ahead of print] Erratum in: Neuroradiology. 2022 Nov 9;:.
• 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.
• 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.
• Ma G, Sun X, Cheng H, Burgin WS, Luo W, Jia W, Liu Y, He W, Geng X, Zhu L, Chen X, Shi H, Xu H, Zhang L, Wang A, Mo D, Ma N, Gao F, Song L, Huo X, Deng Y, Liu L, Luo G, Jia B, Tong X, Liu L, Ren Z, Miao Z; EPOCH Study and ANGEL-ACT Study Groups. Combined Approach to Eptifibatide and Thrombectomy in Acute Ischemic Stroke Because of Large Vessel Occlusion: A Matched-Control Analysis. Stroke. 2022 May;53(5):1580-1588. doi: 10.1161/STROKEAHA.121.036754. Epub 2022 Feb 2.
• Sun D, Jia B, Tong X, Kan P, Huo X, Wang A, Raynald, Ma G, Ma N, Gao F, Mo D, Song L, Sun X, Liu L, Deng Y, Li X, Wang B, Luo G, Wang Y, Ren Z, Miao Z; ANGEL-ACT study group. Predictors of parenchymal hemorrhage after endovascular treatment in acute ischemic stroke: data from ANGEL-ACT Registry. J Neurointerv Surg. 2022 Jan 12. pii: neurintsurg-2021-018292. doi: 10.1136/neurintsurg-2021-018292. [Epub ahead of print]
• Ding Y, Gao F, Ji Y, Zhai T, Tong X, Jia B, Wu J, Wu J, Zhang Y, Wei C, Wang W, Zhou J, Niu J, Miao Z, Liu Y. Workflow Intervals and Outcomes of Endovascular Treatment for Acute Large-Vessel Occlusion During On-Vs. Off-hours in China: The ANGEL-ACT Registry. Front Neurol. 2021 Dec 21;12:771803. doi: 10.3389/fneur.2021.771803. eCollection 2021.
• 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.
• Sun D, Tong X, Huo X, Jia B, Raynald, Wang A, Ma G, Ma N, Gao F, Mo D, Song L, Sun X, Liu L, Deng Y, Li X, Wang B, Luo G, Wang Y, Miao Z; ANGEL-ACT study group. Unexplained early neurological deterioration after endovascular treatment for acute large vessel occlusion: incidence, predictors, and clinical impact: Data from ANGEL-ACT registry. J Neurointerv Surg. 2022 Sep;14(9):875-880. doi: 10.1136/neurintsurg-2021-017956. Epub 2021 Sep 30.
• 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.
• Tong X, Wang Y, Bauer CT, Jia B, Zhang X, Huo X, Luo G, Wang A, Ma N, Gao F, Mo D, Song L, Sun X, Liu L, Deng Y, Li X, Wang B, Ma G, Wang Y, Ren Z, Miao Z. Current status of aspiration thrombectomy for acute stroke patients in China: data from ANGEL-ACT Registry. Ther Adv Neurol Disord. 2021 Apr 12;14:17562864211007715. doi: 10.1177/17562864211007715. eCollection 2021.
• Tong X, Wang Y, Fiehler J, Bauer CT, Jia B, Zhang X, Huo X, Luo G, Wang A, Pan Y, Ma N, Gao F, Mo D, Song L, Sun X, Liu L, Deng Y, Li X, Wang B, Ma G, Wang Y, Ren Z, Miao Z; ANGEL-ACT Study Group. Thrombectomy Versus Combined Thrombolysis and Thrombectomy in Patients With Acute Stroke: A Matched-Control Study. Stroke. 2021 May;52(5):1589-1600. doi: 10.1161/STROKEAHA.120.031599. Epub 2021 Mar 4.
• Jia B, Ren Z, Mokin M, Burgin WS, Bauer CT, Fiehler J, Mo D, Ma N, Gao F, Huo X, Luo G, Wang A, Pan Y, Song L, Sun X, Zhang X, Gui L, Song C, Peng Y, Wu J, Zhao S, Zhao J, Zhou Z, Li Y, Jing P, Yang L, Liu Y, Zhao Q, Liu Y, Peng X, Gao Q, Guo Z, Chen W, Li W, Cheng X, Xu Y, Zhang Y, Zhang G, Lu Y, Lu X, Wang D, Wang Y, Li H, Ling L, Peng G, Zhang J, Zhang K, Li S, Qi Z, Xu H, Tong X, Ma G, Liu R, Guo X, Deng Y, Leng X, Leung TW, Liebeskind DS, Wang Y, Wang Y, Miao Z; ANGEL-ACT Study Groupdagger. Current Status of Endovascular Treatment for Acute Large Vessel Occlusion in China: A Real-World Nationwide Registry. Stroke. 2021 Apr;52(4):1203-1212. doi: 10.1161/STROKEAHA.120.031869. Epub 2021 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2017
• Primary Completion (Actual): July 7, 2019
• Study Completion (Actual): July 7, 2019

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: endovascular treatment; ischemic stroke; registry
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Stroke; Infarction; Emergencies; Ischemic Stroke
• Other Study ID Numbers: 2016YFC1301501-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No