AzTrials
AzTrials

Acute Ischemic StrokeNCT06016348

PROMISE: PRedictors Of Good outcoMes in Thrombectomy for Large Infarct Core Stroke Evaluation

An observational study of Acute Ischemic Stroke, run by 115 People's Hospital at 4 sites in Vietnam.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Endovascular treatment
Type of treatment
Surgery or procedure
How many people
400 participants
Where
4 sitesVietnam
Study dates
28 Jul 2023to 26 Aug 2025
How long will I take part?
365 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
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Vietnam4 sites

  • Can Tho Central General Hospital

    Can Tho

  • Da Nang Stroke Center

    Da Nang

  • 115 PEOPLE's HOSPITAL

    Ho Chi Minh City, 70000

  • University Medical Center

    Ho Chi Minh City, 70000

Other trials in Vietnam

About this study

Official title: Predictors of Good Outcomes in Thrombectomy for Stroke Patients Within 24 Hours From Symptom Onset With Large Infarct Core

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.

Read the detailed description

In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated the effectiveness and safety of endovascular intervention using clot retrieval devices in participants with acute ischemic stroke and large core infarcts. However, the rate of participants achieving a good recovery remains low, while the mortality and disability rates are very high.

Moreover, in Vietnam, the acute stroke treatment process has not been optimized, and the facilities and equipment for monitoring neurointensive care are not fully equipped. As a result, endovascular intervention using clot retrieval devices in participants with large core infarcts has not been widely implemented in the investigator's country, and the effectiveness and safety of this treatment method have not been clearly evaluated.

Addressing this issue is crucial for improving the quality of life and reducing the mortality and disability rates caused by stroke in this participant group. This study aims to provide new insights into the use of endovascular intervention for treating acute ischemic stroke with a large core infarct volume, thereby supporting clinical decision-making and improving treatment outcomes for participants with acute ischemic stroke and large core infarcts.

We hypothesize that core infarction is not the sole factor for excluding patients from potent thrombectomy therapy. We aim to determine predictors of favorable and unfavorable outcomes following thrombectomy in patients with large core strokes. Secondly, we aim to build a multivariable calculator to predict good or poor outcomes after thrombectomy.

Being tested
Endovascular treatment
Keywords
large core, Low ASPECTS, Endovascular treatment
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Endovascular treatmentProcedure or surgery

    Also called Mechanical thrombectomy

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

Study groups in NCT06016348
Study groupRoleWhat they receive
Good outcomemRS of 0-3; mRS of 0-2
Receives: Procedure: Endovascular treatment
Unfavorable outcomesmRS of 4-6
Receives: Procedure: Endovascular treatment

What is being measured

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

  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.

    Measured: 90 (± 14 days) after procedure

Secondary outcomes (4)

  1. mRS of 0-2

    The rate of functional independence (mRS 0-2)

    Measured: 90 (± 14 days) after procedure

  2. mRS of 0-5

    The survival rate

    Measured: 90 (± 14 days) after procedure

  3. Symptomatic intracerebral hemorrhage (sICH)

    sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

    Measured: 72 hours

  4. Early neurological deterioration

    Clinical worsening that was higher by ≥4 points than the value at baseline during the first 72 h after ischaemic stroke.

    Measured: 72 hours

Timeline

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

  1. First posted29 Aug 2023
  2. Study start28 Jul 2023
  3. Primary completion1 Aug 2025
  4. Study completion26 Aug 2025

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
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
Target duration
365 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06016348
Sponsor's protocol ID
115
Status last verified
Aug 2025
First submitted
17 Aug 2023
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 35138767

  • 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.

    PubMed 36762865

  • 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.

    PubMed 36762852

  • Le TQ, Nguyen SVD, Pham TP, Tran TV, Nguyen TQ, Yahanda AT, Dmytriw AA, Huynh VT, Duong HQ, Nguyen TT, Le ND. Thrombectomy improves functional outcome in large core stroke partly by preventing severe cerebral edema: a real-world mediation analysis. Front Neurol. 2026 Oct 16;17:1936247. doi: 10.3389/fneur.2026.1936247. eCollection 2026.

    PubMed 42964142

  • 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.

    PubMed 41608713

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke, run by 115 People's Hospital at 4 sites in Vietnam.

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 8 inclusion and 6 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Vietnam. 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?

The Modified Rankin Scale (mRS) of 0-3 (time frame: 90 (± 14 days) after procedure). 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 NCT06016348, which also lists 5 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 2 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in