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Enrolling by invitationNCT06924996Updated Apr 13, 2025

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

An observational study in Acute Basilar Artery Occlusion and Posterior Circulation Large Infarct, sponsored by Feng Gao. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by Feng Gao · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Acute Basilar Artery Occlusion
  • Posterior Circulation Large Infarct

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03

In context

Infarction

71 studies on the registry are indexed under Infarction; 15 are open to participants now.

This study's planned enrollment of 500 is above the median of 119 across 23 observational studies indexed under Infarction.

Browse Infarction studies →

Lead sponsor

Feng Gao is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Acute basilar artery occlusion with large infarct

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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. 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • 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)

  • Best Medical Management (BMM)

    BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations.

Interventions

  • ProcedureEndovascular 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

06

What researchers measure

Primary outcomes

  1. Rate of modified Rankin scale 0-3 at 90 (±14) days after enrollment

    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.

    Time frame: 90 (±14) days

Secondary outcomes

  1. Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment

    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.

    Time frame: 90 (±14) days

  2. Rate of mRS 0-2 at 90 (±14) days after enrollment

    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.

    Time frame: 90 (±14) days

  3. Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment

    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

    Time frame: 90 (±14) days

Other outcomes

  1. Mortality within 90 (±14) days

    all-cause mortality

    Time frame: 90 (±14) days

  2. Rate of Symptomatic intracranial hemorrhage (SICH)

    Symptomatic intracranial hemorrhage (SICH) within 24-72 hours after enrollment

    Time frame: 24-72 hours

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06924996
Lead sponsor
Feng Gao
Responsible party
Feng Gao (Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University) — Sponsor-investigator
First posted
Apr 13, 2025
Start date
Jan 1, 2023
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 13, 2025

Study contacts

gao feng, professor
study chair · Beijing Tiantan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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