NCT06016348

Brief Summary

Identify the factors associated with a favorable clinical outcome in participants with acute ischemic stroke and large core infarcts within 24 hours of onset who are treated with endovascular intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 17, 2023

Last Update Submit

August 26, 2025

Conditions

Acute Ischemic Stroke

Keywords

large coreLow ASPECTSEndovascular treatment

Outcome Measures

Primary Outcomes (1)

  • The Modified Rankin Scale (mRS) of 0-3

    The rate of independent ambulation (mRS 0-3). The scale runs from 0-6, running from perfect health without symptoms to death.

    90 (± 14 days) after procedure

Secondary Outcomes (4)

  • mRS of 0-2

    90 (± 14 days) after procedure

  • mRS of 0-5

    90 (± 14 days) after procedure

  • Symptomatic intracerebral hemorrhage (sICH)

    72 hours

  • Early neurological deterioration

    72 hours

Study Arms (2)

Good outcome

mRS of 0-3; mRS of 0-2

Procedure: Endovascular treatment

Unfavorable outcomes

mRS of 4-6

Procedure: Endovascular treatment

Interventions

Endovascular treatmentPROCEDURE

This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.

Also known as: Mechanical thrombectomy
Good outcomeUnfavorable outcomes

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients underwent mechanical thrombectomy within 24 hours from symptom onset.

You may qualify if:

  • Age ≥ 18-year-old
  • Patients presenting with acute ischaemic stroke within 24 hours of stroke onset
  • Received mechanical thrombectomy within 24 hours of stroke onset
  • Imaging criteria include:
  • Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem occlusion of the internal carotid artery and middle cerebral artery or internal carotid artery.
  • Core infarct criteria:
  • ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
  • ASPECTS score \>5 and core infarct volume of 50-150 ml on CT perfusion (CTP) or reduced cerebral blood flow (rCBF) \<30% on CTP or apparent diffusion coefficient (ADC) \<620 × 10-6 mm2/s on DWI.

You may not qualify if:

  • Patients presenting with acute ischaemic stroke \>24 hours of stroke onset
  • Intracranial hemorrhage identified by CT or MRI
  • Pre-stroke modified Rankin Score (mRS) score of \>2 (indicating previous disability)
  • Any terminal illness such that the patient has a life expectancy of less than 1 year.
  • Patients with active cancer and undergoing treatment for cancer are excluded,
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Can Tho Central General Hospital

Can Tho, Vietnam

Location

Da Nang Stroke Center

Da Nang, Vietnam

Location

115 PEOPLE's HOSPITAL

Ho Chi Minh City, 70000, Vietnam

Location

University Medical Center

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (4)

  • Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.

    PMID: 35138767BACKGROUND

  • Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.

    PMID: 36762865BACKGROUND

  • Huo X, Ma G, Tong X, Zhang X, Pan Y, Nguyen TN, Yuan G, Han H, Chen W, Wei M, Zhang J, Zhou Z, Yao X, Wang G, Song W, Cai X, Nan G, Li D, Wang AY, Ling W, Cai C, Wen C, Wang E, Zhang L, Jiang C, Liu Y, Liao G, Chen X, Li T, Liu S, Li J, Gao F, Ma N, Mo D, Song L, Sun X, Li X, Deng Y, Luo G, Lv M, He H, Liu A, Zhang J, Mu S, Liu L, Jing J, Nie X, Ding Z, Du W, Zhao X, Yang P, Liu L, Wang Y, Liebeskind DS, Pereira VM, Ren Z, Wang Y, Miao Z; ANGEL-ASPECT Investigators. Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct. N Engl J Med. 2023 Apr 6;388(14):1272-1283. doi: 10.1056/NEJMoa2213379. Epub 2023 Feb 10.

    PMID: 36762852RESULT

  • Le TQ, Nguyen SVD, Tran TV, Pham TP, Le NV, Nguyen DT, Nguyen HH, Pham HVN, Ngo TK, Nguyen TQ, Pham TN, Cao HV, Huynh VT, Duong HQ, Chen CH, Nguyen TT. Large Core Thrombectomy: Feasibility of Simplified Protocol in Resource-Limited Settings. Stroke Vasc Interv Neurol. 2025 Sep 23;5(6):e001810. doi: 10.1161/SVIN.125.001810. eCollection 2025 Nov.

    PMID: 41608713DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
365 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 29, 2023

Study Start

July 28, 2023

Primary Completion

August 1, 2025

Study Completion

August 26, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
60 days

Locations

VN(4)