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

August 26, 2025 updated by: Trung Nguyen, 115 People's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Vietnam
      • Can Tho, Vietnam
        • Can Tho Central General Hospital
      • Da Nang, Vietnam
        • Da Nang Stroke Center
      • Ho Chi Minh City, Vietnam, 70000
        • University Medical Center
      • Ho Chi Minh City, Vietnam, 70000
        • 115 People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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:

      1. ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
      2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Good outcome
mRS of 0-3; mRS of 0-2
Procedure: Endovascular treatment
This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.
Other Names:
  • Mechanical thrombectomy
Unfavorable outcomes
mRS of 4-6
Procedure: Endovascular treatment
This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.
Other Names:
  • Mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 (± 14 days) after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mRS of 0-2
Time Frame: 90 (± 14 days) after procedure
The rate of functional independence (mRS 0-2)
90 (± 14 days) after procedure
mRS of 0-5
Time Frame: 90 (± 14 days) after procedure
The survival rate
90 (± 14 days) after procedure
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.
72 hours
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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
115 People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

60 days

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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