Actively Recruiting
Patient Selection Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours
Led by Tianjin Huanhu Hospital · Updated on 2024-06-24
352
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We will conduct a multicenter, prospective, randomized, open-label, blinded endpoint trial with a non-inferiority design in patients who present 6 to 24 hours after symptom onset with LVO. Patients who meet eligibility criteria will be randomly assigned to the Non-perfusion or Perfusion group with a 1:1 ratio. In the Non-perfusion group, patients with penumbra-core mismatch (defined as the FLAIR Vascular Hyperintensity (FVH) extending beyond the boundary of the DWI cortical lesions) will receive EVT. In the Perfusion group, patients with perfusion mismatch (defined as regional cerebral blood flow (\<30%) \< 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml) will receive EVT. Patients in both groups will receive guideline-based medical treatment. If patients in both groups do not meet the criteria for EVT, only guideline-based medical treatment will be administered.
CONDITIONS
Official Title
Patient Selection Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Confirmed anterior circulation large vessel occlusion by CTA or MRA
- NIH Stroke Scale score of 6 or higher at randomization
- ASPECTS score of 6 or higher on non-contrast CT
- Time from stroke onset to randomization within 6 to 24 hours
- Pre-stroke modified Rankin Scale score of 0 to 2
- Completed or able to complete MRI and perfusion imaging
- Signed informed consent
You will not qualify if you...
- Pregnancy or positive pregnancy test
- History of severe allergy to contrast media
- Uncontrolled hypertension (systolic >185 mmHg or diastolic >110 mmHg)
- Bleeding tendency, coagulation factor deficiency, or recent anticoagulant medication
- Active bleeding or preexisting bleeding risk
- Signs of heart, liver, or kidney failure
- Blood glucose less than 50 mg/dL or greater than 400 mg/dL
- Participation in other interventional randomized clinical trials
- Life expectancy less than 1 year
- Unable to complete 90-day follow-up
- Stroke with epilepsy preventing accurate NIHSS scoring
- Other reasons deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
TianJinHH
Tianjin, Tianjin Municipality, China, 300222
Actively Recruiting
Research Team
M
Ming Wei, doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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