The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction

December 30, 2025 updated by: Feng Gao, Beijing Tiantan Hospital

The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial

This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)

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.
Interventional

Enrollment (Estimated)

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.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:

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

No

Description

Inclusion Criteria:

  1. The age ranged from 18 to 80 years
  2. Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
  3. Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
  4. Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
  5. NIHSS score ≥10 before randomization
  6. Pre-stroke mRS of 0-2
  7. Each patient or their legal representative must provide written informed consent before enrolment

Exclusion Criteria:

  1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
  2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
  3. Known or highly suspected chronic occlusion of basilar artery
  4. History of contraindication for contrast medium (except mild rash)
  5. Current pregnant or breast-feeding
  6. Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
  7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
  8. It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
  9. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
  10. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
  11. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
  12. CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
  13. Central nervous system vasculitis has been diagnosed or clinically suspected
  14. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
  15. Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
  16. Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Endovascular Treatment Group
Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded posterior circulation vessel using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist.
Procedure: Endovascular Recanalization Strategy
The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Other: Best Medical Management Group
Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization.
Drug: Best Medical Management
Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy.

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
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
Time Frame: 90±14 days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
90±14 days after randomization

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
Rate of mRS 0-2 at 90 (±14) days after randomization
Time Frame: 90±14 days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
90±14 days after randomization
MRS score as an ordinal scale at 90 (±14) days after randomization
Time Frame: 90±14 days after randomization
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
90±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
Time Frame: 24 hours after randomization
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
24 hours after randomization
NIHSS score at 7 days after randomization or discharge (whichever came first)
Time Frame: 7 days after randomization or at discharge
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
7 days after randomization or at discharge
Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization
Time Frame: 90±14 days after randomization
EuroQol Five Dimensions (EQ-5D) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
90±14 days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization
Time Frame: 90±14 days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization.
90±14 days after randomization
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD)
Time Frame: 18-36 hours after randomization
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
18-36 hours after randomization
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3)
Time Frame: At the end of the operation
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3).
At the end of the operation
The proportion of mRS 0-4 at 90 (± 14) days after randomization
Time Frame: 90±14 days after randomization
The proportion of mRS 0-4 at 90 (± 14) days after randomization.
90±14 days after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause of mortality within 90 (±14) days after randomization
Time Frame: 90±14 days after randomization
All cause of mortality within 90 (±14) days after randomization
90±14 days after randomization
All cause of mortality within 7 days after randomization
Time Frame: 7 days after randomization
All cause of mortality within 7 days after randomization
7 days after randomization
Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 18-36 hours of randomization
Time Frame: 18-36 hours after randomization
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.
18-36 hours after randomization
Rate of any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization
Time Frame: Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours.
Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 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.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Feng Gao, MD, Beijing Tiantan Hospital

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 (Estimated)

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.
January 1, 2026

Primary Completion (Estimated)

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.
December 31, 2027

Study Completion (Estimated)

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.
December 31, 2028

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).
December 22, 2025

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.
December 30, 2025

First Posted (Estimated)

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.
January 12, 2026

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.
January 12, 2026

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.
December 30, 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.
December 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.
  • HX-A-2025081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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