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OpenTrials
Enrolling by Invitation

NCT Number: NCT06510634

Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion

Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.

Enrolling by Invitation

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Who can participate

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

Inclusion criteria

  • age≥18 years.;
  • blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);
  • VBAO occurrence more than 24 hours from LKW;
  • none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;
  • informed consent before enrollment in the clinical trials.

Exclusion criteria

  • neuroimaging evidence of cerebral hemorrhage on presentation;
  • lack of follow up information on outcomes at 90 days
  • serious, advanced, or terminal illness.

Treatment and study plan

Endovascular Therapy

Other

Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging.

Endovascular therapy includes any one or more of the following:

Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.

Primary outcomes

  1. proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days

    Time frame: 90(±14)days

    A 0-6 scale running from perfect health without symptoms to death.

Secondary outcomes

  1. distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days

    Time frame: 90(±14)days

    A 0-6 scale running from perfect health without symptoms to death.

  2. Mortality within 90 days

    Time frame: 90(±14)days

    mortality of any causes.

  3. Incidence of symptomatic intracranial haemorrhage

    Time frame: 90(±14)days

    Symptomatic intracranial hemorrhage was characterized as any type of intracranial hemorrhage observed on follow-up imaging between 22 and 36 hours and 7 days after stroke onset, accompanied by an increase of at least 4 points on the NIHSS from baseline or the lowest value within 7 days, or resulting in mortality.

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Registry information

Official study title

Effectiveness and Safety of Endovascular Treatment vs. Best Medical Treatment in Patients With Vertebrobasilar Artery Occlusion Presenting Beyond 24 Hours of Last Known Well:a Prospective, Multicenter Registry Study

Acronym: VBAO-LATE

Important dates

Study start
2019
Primary completion
2024
Study completion
2028
First posted
Jul 19, 2024
Registry last updated
Feb 28, 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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