Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06560203

Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window

Led by Capital Medical University · Updated on 2024-09-19

309

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

CONDITIONS

Official Title

Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset or last seen well, excluding isolated vertigo, with ineligibility or contraindication for IV thrombolytic treatment or no recanalization after IV thrombolysis
  • Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries confirmed by imaging
  • Age between 18 and 80 years
  • Baseline NIH Stroke Scale score of 6 points or higher
  • No significant disability before stroke (modified Rankin Scale 0-1)
  • Treatable within 72 hours of symptom onset
  • Informed consent obtained from patient or authorized surrogate
Not Eligible

You will not qualify if you...

  • Known bleeding disorders, coagulation factor deficiency, or oral anticoagulant therapy with INR greater than 3.0
  • Baseline platelet count less than 50,000 per microliter
  • Blood glucose below 50 mg/dL or above 400 mg/dL
  • Severe sustained high blood pressure (systolic > 220 mm Hg or diastolic > 110 mm Hg) unless controlled
  • Inability to obtain baseline NIH Stroke Scale score prior to sedation or intubation
  • Seizures at stroke onset preventing baseline assessment
  • Advanced or terminal illness with life expectancy under one year
  • History of life-threatening allergy to contrast medium
  • Acute stroke within 48 hours after major cardiac, cerebrovascular interventions, or surgery
  • Renal insufficiency with creatinine level 3 mg/dL or higher
  • Pregnant or lactating women
  • Participation in another investigational drug or device study affecting this trial
  • Known or suspected cerebral vasculitis
  • Pre-existing neurological or psychiatric disease affecting evaluations
  • Unlikely to be available for 90-day follow-up
  • Other conditions posing significant risk as judged by the investigator
  • Imaging evidence of severe brain infarcts, hemorrhage, or vascular issues preventing treatment access or safe device delivery
  • Occlusions in both anterior and posterior circulation
  • Presence of intracranial tumors except small meningiomas

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xuanwu hospital

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

X

Xunming Ji

CONTACT

C

Chuanhui Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window | DecenTrialz