Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03502408

Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-11-23

55

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.

CONDITIONS

Official Title

Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical signs and symptoms consistent with acute ischemic stroke
  • Age 18 years or older
  • National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher
  • Endovascular thrombectomy can be started between 6 and 24 hours after last known well
  • No significant disability before the stroke (pre-stroke modified Rankin Scale 3 or less)
  • Patient or legal representative has signed informed consent
  • Imaging shows blockage in ICA, MCA-M1, MCA-M2, or basilar artery
  • Target Mismatch Profile on CT or MR perfusion: ischemic core volume 70 ml or less and mismatch ratio 1.2 or higher
Not Eligible

You will not qualify if you...

  • Serious, advanced, or terminal illness with life expectancy less than 90 days
  • Co-morbid conditions affecting neurological or functional evaluation or survival
  • Unable to undergo contrast brain perfusion MRI or CT scan
  • Pregnant
  • Known serious allergy to radiographic contrast agents
  • Treated with rtPA more than 6 hours after last known well
  • Known bleeding disorders or coagulation factor deficiencies
  • Recent oral anticoagulant therapy with INR above 3 (except new oral anticoagulants if kidney function is adequate)
  • Seizures at stroke onset preventing accurate baseline assessment
  • Participation in another investigational drug or device study
  • Any condition that prevents safe endovascular procedure or poses significant risk
  • ASPECTS score below 6 on non-contrast CT (if enrolled based on CT perfusion)
  • Evidence of intracranial tumor (except small meningioma), hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
  • Significant brain swelling with midline shift
  • Internal carotid artery dissection
  • Intracranial stent in the same blood vessel area or arterial disease preventing thrombectomy device use

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

M

MIN LOU, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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