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Completed

NCT Number: NCT06016348

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Can Tho Central General Hospital, Can Tho, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

endovascular treatment

Procedure

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

Other names: Mechanical thrombectomy

Primary outcomes

  1. The Modified Rankin Scale (mRS) of 0-3

    Time frame: 90 (± 14 days) after procedure

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

Secondary outcomes

  1. mRS of 0-2

    Time frame: 90 (± 14 days) after procedure

    The rate of functional independence (mRS 0-2)

  2. mRS of 0-5

    Time frame: 90 (± 14 days) after procedure

    The survival rate

  3. Symptomatic intracerebral hemorrhage (sICH)

    Time frame: 72 hours

    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.

  4. Early neurological deterioration

    Time frame: 72 hours

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

Sponsors and collaborators

Lead sponsor

115 People's Hospital

Other Gov

Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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