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Intracranial Artery Occlusion With Infarction (Disorder)ANGEL-ACTNCT03370939

Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke

An observational study of Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,004 participants
Where
1 siteChina
Study dates
11 Nov 2017to 7 Jul 2019
How long will I take part?
90 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Age ≥ 18 years old;
  • Diagnosis of acute ischemic stroke;
  • 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);
  • Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting;
  • The patient or the patient's legal representative is able and willing to sign the informed consent.

Who cannot join

  • Isolated cervical ICA or VA occlusion;
  • No evidence of LVO on DSA.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: 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.

Keywords
ischemic stroke, endovascular treatment, registry
Medical subject headings
Ischemic Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90±7 days after enrollment

  2. 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

    Measured: 12-36 hours after the procedure

  3. Time from symptom onset to recanalization

    Measured: The end of the procedure

Secondary outcomes (14)

  1. Recanalization rate at the end of the procedure

    mTICI score 2b-3

    Measured: at the end of the procedure

  2. Recanalization rate after the first attempt

    mTICI score 2b-3

    Measured: At baseline, during the procedure, after the first attempt of endovascular treatment

  3. Changes in NIHSS score immediately after the procedure

    difference between NIHSS score immediately after the procedure and baseline

    Measured: within 2 hours after the procedure

  4. Changes in NIHSS score 24 hours after the procedure

    difference between NIHSS score 24 hours after the procedure and baseline

    Measured: 24 hours after the procedure

  5. 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

    Measured: 7 days after the procedure or discharge

  6. 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.

    Measured: 90±7 days after the procedure

  7. Barthel index (BI) 90 days after the procedure

    The BI has a score of 0-100. A higher score indicates a better outcome.

    Measured: 90±7 days after the procedure

  8. Parenchymal hematoma (PH2)

    PH2 is defined as hematoma in >30% of infarct area

    Measured: 12-36 hours after the procedure

  9. Any intracranial hemorrhage on imaging

    Measured: 12-36 hours after the procedure

  10. All-cause mortality within 90 days

    Measured: 90±7 days after the procedure

  11. Time from onset to arrival

    Measured: At baseline, after arrival at the hospital

  12. Time from arrival to imaging

    Measured: At baseline, after taking any brain imaging

  13. Time from imaging to puncture

    Measured: At baseline, during the procedure, after successful groin puncture

  14. Time from puncture to recanalization

    Measured: At baseline, during the procedure, after successful recanalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start11 Nov 2017
  3. Primary completion7 Jul 2019
  4. Study completion7 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
2,004 participants (actual)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03370939
Sponsor's protocol ID
2016YFC1301501-1
Acronym
ANGEL-ACT
Status last verified
May 2020
First submitted
18 Oct 2017
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Han B, Raynald, Firdaus M, Sun D, Wu Y, XuTong, Jia B, Wang A, Mo D, Gao F, Ma N, Sun Y, Miao Z. Early neurological deterioration after endovascular treatment in acute ischemic stroke with large vessel occlusion. BMC Neurol. 2026 Jul 29;26(1):669. doi: 10.1186/s12883-026-05150-7.

    PubMed 42928143

  • Bu Z, Sun D, Zhang X, Ma N, Gao F, Mo D, Meng Q, Miao Z; ANGEL-ACT study group. The role of intravenous tirofiban in patients undergoing endovascular treatment for acute intracranial atherosclerotic occlusion. J Stroke Cerebrovasc Dis. 2025 Oct;34(10):108420. doi: 10.1016/j.jstrokecerebrovasdis.2025.108420. Epub 2025 Aug 11.

    PubMed 40803585

  • Tong X, Jia B, Ma G, Zhang X, Fiehler J, Flottmann F, Bechstein M, Broocks G, Hanning U, Kniep HC, Thomalla G, Deb-Chatterji M, Schon G, Zhang Y, Gao F, Ma N, Mo D, Miao Z, Meyer L; as the ANGEL-ACT & GSR-ET study group. Relationship Between Thrombolysis-to-Puncture Time and Outcomes of Endovascular Thrombectomy in Acute Ischemic Stroke. Neurol Clin Pract. 2025 Aug;15(4):e200434. doi: 10.1212/CPJ.0000000000200434. Epub 2025 Jul 11.

    PubMed 40656129

  • Bu Z, Sun D, Ma G, Jia B, Tong X, Huo X, Wang A, Ma N, Gao F, Mo D, Song L, Sun X, Deng Y, Li X, Wang B, Luo G, Su D, Miao Z. The impact of intraarterial, intravenous, and combined tirofiban on endovascular treatment for acute intracranial atherosclerotic occlusion. Front Neurol. 2024 Feb 13;15:1336098. doi: 10.3389/fneur.2024.1336098. eCollection 2024.

    PubMed 38414555

  • Li L, Lv J, Han JJ, Gao Y, Yan ZX, Wu Q, Zhang XL, Gao F. Nomogram model of functional outcome for endovascular treatment in patients with acute basilar artery occlusion. Front Neurol. 2023 Oct 19;14:1277189. doi: 10.3389/fneur.2023.1277189. eCollection 2023.

    PubMed 37928150

  • Deng Y, Yao Y, Tong X, Yin Y, Wang A, Zhang Y, Jia B, Huo X, Luo G, Ma N, Mo D, Song L, Sun X, Gao F, Chen D. Necessity and timing of angioplasty in acute large-vessel occlusion strokes due to intracranial atherosclerotic disease: A cohort analysis with data from the angel-ACT registry. Front Neurol. 2023 Mar 16;14:1087816. doi: 10.3389/fneur.2023.1087816. eCollection 2023.

    PubMed 37006506

  • Sun D, Huo X, Raynald, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Miao Z; ANGEL-ACT study group. First pass effect of mechanical thrombectomy for acute vertebrobasilar artery occlusion: data from the ANGEL-ACT registry. J Neurointerv Surg. 2023 Dec;15(12):1201-1206. doi: 10.1136/jnis-2023-020065. Epub 2023 Feb 1.

    PubMed 36725361

  • Sun D, Raynald, Huo X, Jia B, Tong X, Ma G, Wang A, Ma N, Gao F, Mo D, Nguyen TN, Miao Z; ANGEL-ACT Study Group. Sex-Related Differences in Outcomes of Endovascular Treatment for Anterior Circulation Large Vessel Occlusion. Stroke. 2023 Feb;54(2):327-336. doi: 10.1161/STROKEAHA.122.041195. Epub 2023 Jan 23.

    PubMed 36689588

  • Li K, Sun D, Tong X, Wang A, Zhang Y, Ma G, Huo X, Ma N, Gao F, Mo D, Sun X, Peng G, Zhang X, Jia B, Miao Z. Incidence, predictors, and impact on outcome of underlying intracranial atherosclerotic disease in acute vertebrobasilar artery occlusion undergoing endovascular therapy: Data from ANGEL-ACT registry. Int J Stroke. 2023 Aug;18(7):856-863. doi: 10.1177/17474930221150111. Epub 2023 Jan 14.

    PubMed 36571164

  • 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.

    PubMed 36274108

  • 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.

    PubMed 35354298

  • 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.

    PubMed 35243592

  • 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.

    PubMed 35105182

  • 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. 2023 Jan;15(1):20-26. doi: 10.1136/neurintsurg-2021-018292. Epub 2022 Jan 12.

    PubMed 35022299

  • 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.

    PubMed 34992575

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional independence at 90 days (modified Rankin Scale of 0-2) (time frame: 90±7 days after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03370939, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.

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