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Acute Ischemic StrokeANGEL-ASPECTNCT04551664

Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core

A study testing Best medical management and Endovascular therapy in people with Acute Ischemic Stroke, 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 therapy (EVT) was recommended as the primary treatment for patients with acute large vascular occlusion (LVO) in anterior circulation. However, the evidences of EVT for patients with large infarct volume were limited. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Best medical management and Endovascular therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
1 siteChina
Study dates
2 Oct 2020to 30 May 2023
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • 18 to 80 years of age
  • Presenting with symptoms consistent with an AIS
  • Pre-stroke mRS score 0-1
  • NIHSS score 6-30 at the time of randomization
  • Randomization can be finished within 24 hours of stroke onset (stroke onset time is defined as last known well time)
Show all 12Show fewer
  • Informed consent signed Specific Neuroimaging Inclusion Criteria
  • CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery
  • Combination of NCCT ASPECTS and perfusion core volume when ASPECTS <3 or > 5 (6h-24h). Imaging evidence of low ASPECTS (based on NCCT) or large infarct Core (defined as rCBF <30% on CT perfusion or ADC<620 on MRI) filling one of the following criteria:
  • ASPECTS 3-5
  • ASPECTS >5 (6h-24h) with infarct core volume 70-100 ml
  • ASPECTS <3 with infarct core volume 70-100 ml

Who cannot join

  • General Exclusion Criteria
  • Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
  • Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
  • Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
  • Known hemorrhagic tendency (including but not limited to): Baseline platelet count <100×109/L; Heparin was administered within 48 hours with APTT≥35s; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) > 1.7 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment)
  • Parenchymal organ surgery and biopsy were performed in the past one month
Show all 16Show fewer
  • Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past one month
  • Undergoing hemodialysis or peritoneal dialysis; Known severe renal insufficiency with glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl)
  • Brain tumor (with mass effect)
  • The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
  • Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
  • Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)
  • Specific Neuroimaging Exclusion Criteria
  • Midline shift, herniation or mass effect with effacement of the ventricles
  • Evidence of acute intracranial hemorrhage
  • Acute bilateral strokes or multiple intracranial vessels occlusions

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: Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core: A Multi-centered, Prospective, Open-label, Blind Endpoint， Randomized Controlled Trial（ANGEL-ASPECT）

Endovascular therapy (EVT) was recommended as the primary treatment for patients with acute large vascular occlusion (LVO) in anterior circulation. However, the evidences of EVT for patients with large infarct volume were limited. In this study, the investigators assume that best medical management plus EVT might be superior than best medical management alone for patients who have evidence of a large infarct volume. The primary objective of the study was to establish the safety and efficacy of EVT in patients presenting with symptoms of acute ischemic stroke (AIS) from LVO in the anterior circulation and having a large infarct volume.

Read the detailed description

The ANGEL-ASPECT is a multicentered, prospective, randomized, open-label, blinded end-point (PROBE) study. A total of approximately 488 patients (age from 18 to 80 years) within 24 hours of symptom onset of acute ischemic stroke, who has the imaging evidence of an occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment, large infarct core [ defined as: 1) NCCT (noncontrast computed tomography) ASPECTS (Alberta Stroke Program Early CT Score) 3-5, decided on last head CT scan before randomization. 2) Ischemic core volume ranges from 70-100ml, determined either on a diffusion-weighted MRI map based on an ADC (Apparent Diffusion Coefficient) threshold of less than 620 ×10-6mm2/s or on CTP (computed tomography perfusion) image with rCBF<30%] will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive best medical management alone the other group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish the efficacy of EVT in patients presenting with symptoms of acute ischemic stroke (AIS) from LVO in the anterior circulation and having a large infarct volume. The study consists of six visits including the day of randomization, 2 days after randomization, 7 days or discharge, and 30, 90 days and 1 year. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The primary endpoint is the modified Rankin's scale (mRS) at 90 days. The trial is anticipated to last from September 2020 to October 2022 with 488 subjects recruited form about 50 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Being Tiantan hospital, Capital Medical University.

Being tested
Best medical management, Endovascular therapy
Keywords
endovascular therapy, large infarct volume
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best medical managementDrug

    All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.

  • Endovascular therapyProcedure or surgery

    In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy (recommended with Solitaire、EMBOTRAP、Trevo or Reco revascularization device) or aspiration thrombectomy (recommended with Penumbra) will be recommended as the primary treatment.

Study groups in NCT04551664
Study groupRoleWhat they receive
EVT groupExperimentalPatients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.
Receives: Drug: Best medical management; Procedure: Endovascular therapy
Best medical management groupActive comparatorPatients in this group will receive best medical management alone.
Receives: Drug: Best medical management

What is being measured

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

  1. Neurofunctional deficit defined as modified Rankin Scale (mRS)

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

    Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

    Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

    Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

    Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

    Score 6: Dead

    Measured: 90±7 days after randomization

Secondary outcomes (9)

  1. Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard

    Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:

    • 4 points total NIHSS at the time of diagnosis compared to immediately before worsening.
    • 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention.

    Absence of alternative explanation for deterioration.

    Measured: within 48 hours after randomization

  2. 90-day good clinical outcome

    Good clinical outcome defined as a dichotomized mRS 0-2 outcome

    Measured: 90±14 days after randomization

  3. 90-day favorable clinical outcome

    Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome

    Measured: 90±7 days after randomization

  4. Dramatic recovery

    36-hour (24-48 hours) NIHSS score ≤1 or ≥10 points drop as compared with baseline

    Measured: baseline, 36±12 hours after randomization

  5. Change of infarct volume from baseline to 36-hour (24-48 hours)

    The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10-6mm2/s or on CTP image with rCBF<30%

    Measured: baseline, 36±12 hours after randomization

  6. All-cause mortality rate

    All-cause mortality rate at 90±14 days

    Measured: 90±7 days after randomization

  7. Any type of intracranial hemorrhage according to Heidelberg Classification.

    Any type of intracranial hemorrhage according to Heidelberg Classification.

    Measured: 36±12 hours after randomization

  8. Rate of decompressive hemicraniectomy

    Rate of decompressive hemicraniectomy

    Measured: 7±1 days after randomization or discharge

  9. Rate of successful recanalization

    Rate of participants with recanalization of the primary arterial occlusive lesion at 36±12 hours

    Measured: 36±12 hours after randomization

Timeline

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

  1. First posted16 Sep 2020
  2. Study start2 Oct 2020
  3. Primary completion15 Aug 2022
  4. Study completion30 May 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551664
Sponsor's protocol ID
HX-A-011(2020)
Acronym
ANGEL-ASPECT
Status last verified
Oct 2023
First submitted
10 Sep 2020
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao J, Zheng L, Nie X, Wang M, Pu S, Liu X, Duan W, Zhang Z, Liu J, Wei Y, Yang Z, Wen M, Leng X, Huo X, Pan Y, Miao Z, Liu L. Association between ASPECTS regions and clinical outcomes following endovascular therapy in patients with large infarcts: a post hoc analysis of the ANGEL-ASPECT trial. Stroke Vasc Neurol. 2026 Jul 7:svn-2025-004422. doi: 10.1136/svn-2025-004422. Online ahead of print.

    PubMed 42413994

  • Sun D, - R, Nguyen TN, Abdalkader M, Pan Y, Wang M, Ma N, Gao F, Mo D, Huo X, Firdaus M, Miao Z, Song L; ANGEL-ASPECT Study Group. Endovascular treatment for extracranial internal carotid artery occlusions with large infarcts: ANGEL-ASPECT subanalysis. J Neurointerv Surg. 2026 Apr 9:jnis-2026-024978. doi: 10.1136/jnis-2026-024978. Online ahead of print.

    PubMed 41956819

  • Liu C, Wang Z, Wang M, Cai S, Nie X, Huo X, Liu L, Pan Y, Miao Z, Wang Y; ANGEL-ASPECT Study Group. Effects of Computed Tomography Hyperdense Middle Cerebral Artery Sign on the Efficacy of Endovascular Therapy in Acute Ischemic Stroke With Large Infarcts: A Subgroup Analysis of the ANGEL-ASPECT Trial. J Am Heart Assoc. 2026 Apr 7;15(7):e042473. doi: 10.1161/JAHA.125.042473. Epub 2026 Mar 31.

    PubMed 41914357

  • Wang Z, Liu C, Wang M, Cai S, Nie X, Liu L, Huo X, Pan Y, Miao Z, Wang Y; ANGEL-ASPECT Study Group. White matter lesions modifying endovascular therapy outcomes in large ischemic core stroke: A secondary analysis of the ANGEL-ASPECT trial. Chin Med J (Engl). 2026 Mar 20;139(6):855-865. doi: 10.1097/CM9.0000000000003993. Epub 2026 Feb 4.

    PubMed 41641580

  • Chen J, Nie X, Wang M, Zhang D, Sun D, Pan Y, Huo X, Li Z, Miao Z; ANGEL-ASPECT Study Group. Time-Dependent Impact of Mismatch Profiles on Outcomes Following Endovascular Thrombectomy for Large Ischemic Stroke. Stroke. 2026 Mar;57(3):641-649. doi: 10.1161/STROKEAHA.125.052698. Epub 2025 Dec 24.

    PubMed 41439308

  • Li K, Sun D, Wang M, Pu S, Pan Y, Abdalkader M, Liu F, Chen C, Sun P, Yu J, Huo X, Nguyen TN, Miao Z, Han J; ANGEL-ASPECT Investigators. Significance of occlusion site on outcomes in stroke patients with large infarction undergoing endovascular therapy: A prespecified subgroup analysis of the ANGEL-ASPECT trial. Int J Stroke. 2026 Jun;21(5):676-687. doi: 10.1177/17474930251393014. Epub 2025 Nov 29.

    PubMed 41317114

  • Huo X, Sun D, Nguyen TN, Ma G, Pan Y, Tong X, Yuan G, Han H, Chen W, Wei M, Zhang J, Zhou Z, Yao X, Song W, Cai X, Nan G, Li D, Wang AY, Ling W, Cai C, Wen C, Wang E, Zhang L, Jiang C, Liao G, Chen X, Li T, Liu S, Li J, Sun Y, Xu N, Gao Z, Ju D, Song C, Zhou F, Shi Q, Luo J, Liu Y, Guo Z, Zheng H, Dai L, Zhao J, Geng X, Tang Y, Yin C, Yang H, Zhang X, Li S, Abdalkader M, Gao F, Ma N, Mo D, Ren Z, Liu L, Wang Y, Miao Z; ANGEL-ASPECT Investigators. Endovascular Therapy Versus Medical Management for Large Ischemic Infarct: 1-Year Outcomes of the ANGEL-ASPECT Trial. Stroke. 2025 Sep;56(9):2398-2407. doi: 10.1161/STROKEAHA.124.050086. Epub 2025 Aug 25.

    PubMed 40854041

  • Sun D, Guo X, Ling L, Jiao L, Nguyen TN, Abdalkader M, Pan Y, Wang M, Luo G, Jia B, Tong X, Ma N, Gao F, Mo D, Raynald, Huo X, Miao Z; ANGEL-ASPECT Study Group. Sex-Related Differences in Endovascular Treatment Outcomes for Acute Large Infarcts: The ANGEL-ASPECT Subanalysis. Stroke. 2025 Aug;56(8):2033-2042. doi: 10.1161/STROKEAHA.124.050025. Epub 2025 May 9.

    PubMed 40340582

  • Shi Z, Luo G, Huo X, Sun D, Pan Y, Wang M, Ai T, Song L, Li X, Jia B, Wang B, Zhang L, Chen F, Sun Y, Mo D, Gao F, Ma N, Miao Z; ANGEL-ASPECT Study Group. Predictors of parenchymal hemorrhage after endovascular treatment in large core ischemic stroke: a post-hoc analysis of the ANGEL-ASPECT trial. J Neurointerv Surg. 2026 Mar 13;18(4):942-949. doi: 10.1136/jnis-2025-023285.

    PubMed 40280761

  • Lu Q, Zheng L, Nie X, Wang M, Duan W, Liu X, Zhang Z, Wen M, Yang Z, Leng X, Pan Y, Nguyen TN, Liu L. Clinical Severity and Outcomes in Large Infarcts With Endovascular Therapy: A Post Hoc Analysis of the ANGEL-ASPECT Trial. Stroke. 2025 Apr;56(4):1048-1053. doi: 10.1161/STROKEAHA.124.049315. Epub 2025 Feb 27.

    PubMed 40013350

  • Li M, Zheng L, Nie X, Wang M, Liu X, Duan W, Zhang Z, Wen M, Yang Z, Huo X, Leng X, Pan Y, Nguyen TN, Miao Z, Liu L. Endovascular therapy for large ischemic stroke in directly admitted versus transferred patients: A secondary analysis. Int J Stroke. 2025 Jul;20(6):731-740. doi: 10.1177/17474930251325085. Epub 2025 Feb 19.

    PubMed 39972662

  • Yuan G, Sang H, Nguyen TN, Huo X, Pan Y, Wang M, Qiu Z, Liu L, Xia H, Wu J, Long C, Xu J, Huang F, He B, Wu D, Wang H, Feng C, Liang Y, Zhou X, Yang W, Huang Z, Xiang Y, Lei L, Saver JL, Miao Z, Cai X. Association Between Time to Treatment and Outcomes of Endovascular Therapy vs Medical Management in Patients With Large Ischemic Stroke. Neurology. 2025 Jan 14;104(1):e210133. doi: 10.1212/WNL.0000000000210133. Epub 2024 Dec 9.

    PubMed 39652807

  • Zhang L, Chen F, Nguyen TN, Pan Y, Liu Y, Wang M, Li S, Sun D, Huo X, Jia B, Miao Z; ANGEL-ASPECT Study Group. Spontaneous recanalization in acute large core ischemic stroke due to large vessel occlusion: a post-hoc analysis of the ANGEL-ASPECT trial. J Neurointerv Surg. 2025 Dec 17;18(1):91-98. doi: 10.1136/jnis-2024-022357.

    PubMed 39332900

  • Liang F, Zhang K, Wu Y, Wang X, Hou X, Yu Y, Wang Y, Wang M, Pan Y, Huo X, Han R, Miao Z. Anaesthesia modality on endovascular therapy outcomes in patients with large infarcts: a post hoc analysis of the ANGEL-ASPECT trial. Stroke Vasc Neurol. 2025 Apr 29;10(2):e003320. doi: 10.1136/svn-2024-003320.

    PubMed 39160092

  • Zheng L, Nie X, Wang M, Liu X, Duan W, Zhang Z, Liu J, Wei Y, Wen M, Yang Z, Leung TW, Ma G, Huo X, Pan Y, Nguyen TN, Leng X, Miao Z, Liu L; ANGEL-ASPECT Investigators. Endovascular therapy in acute ischaemic stroke with large infarction with matched or mismatched clinical-radiological severities: a post-hoc analysis of the ANGEL-ASPECT trial. EClinicalMedicine. 2024 Apr 12;72:102595. doi: 10.1016/j.eclinm.2024.102595. eCollection 2024 Jun.

    PubMed 38638180

Questions about this trial

What is this clinical trial studying?

A study testing Best medical management and Endovascular therapy in people with Acute Ischemic Stroke, 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 12 inclusion and 16 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 17 Oct 2023. 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?

Neurofunctional deficit defined as modified Rankin Scale (mRS) (time frame: 90±7 days after randomization). 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 NCT04551664, which also lists 17 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 17 Oct 2023.

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