Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct

April 10, 2025 updated by: Feng Gao

Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct: A Multicenter, Prospective, Cohort Study

The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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 study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

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 (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.
500

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan 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

No

Sampling Method

Non-Probability Sample

Study Population

Acute basilar artery occlusion with large infarct

Description

Inclusion Criteria:

  1. Age 18-80 years old;
  2. Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours;
  3. CTA/MRA/DSA confirmed acute basilar artery occlusion;
  4. Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points;
  5. NIHSS score ≥10 points after the onset of the stroke and before enrollment;
  6. Able to live independently before the onset of the disease (mRS score ≤2 points);
  7. The subject or legal representative is able to sign the informed consent form.

Exclusion Criteria:

  1. Intracranial hemorrhage (except microhemorrhage) on CT/MRI ;
  2. CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem;
  3. CT or MRI showed bilateral complete thalamic infarction;
  4. Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA;
  5. The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of <3mm);
  6. Patients with known or highly suspected chronic basilar artery occlusion.;
  7. Known severe allergy to contrast agents (except for mild rash);
  8. Refractory hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by drug therapy;
  9. Known pregnant or lactating females, or positive pregnancy test before enrollment;
  10. Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).

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.
Endovascular Thrombectomy (EVT)
The EVT group would include the following interventions: stent-retriever thrombectomy, aspiration thrombectomy, balloon angioplasty and/or stenting, intra-arterial medication administration, or a combination of these approaches.
Procedure: Endovascular Thrombectomy (EVT)
A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire AB/FR device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion, angioplasty and subsequent stenting through detachment of the Solitaire device will be allowed
Best Medical Management (BMM)
BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations.

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 enrollment
Time Frame: 90 (±14) days
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

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
Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment
Time Frame: 90 (±14) days
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
Rate of mRS 0-2 at 90 (±14) days after enrollment
Time Frame: 90 (±14) days
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
Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment
Time Frame: 90 (±14) days
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

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
Mortality within 90 (±14) days
Time Frame: 90 (±14) days
all-cause mortality
90 (±14) days
Rate of Symptomatic intracranial hemorrhage (SICH)
Time Frame: 24-72 hours
Symptomatic intracranial hemorrhage (SICH) within 24-72 hours after enrollment
24-72 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.
Feng Gao

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.
  • Study Chair: gao feng, professor, 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 (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.
January 1, 2023

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.
August 31, 2025

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, 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).
April 10, 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.
April 10, 2025

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.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

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.
April 13, 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.
April 10, 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.
April 1, 2025

More Information

Terms related to this study

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.
  • KY2023-106-02

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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