Actively Recruiting
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2024-10-24
560
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.
CONDITIONS
Official Title
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Evidence of a primary distal medium vessel occlusion in specified brain artery segments with vessel diameter not exceeding 2.0 mm for co/non-dominant M2 segment
- Age 18 years or older
- Premorbid modified Rankin Scale (mRS) score of 0 to 1
- Disabling stroke defined by NIH Stroke Scale score of 4 or higher, or 2-3 with significant disabling symptoms
- Less than 50% core infarct in the affected territory as shown by imaging
- Treatment started within 4.5 to 24 hours from symptom onset or last seen well
- Informed consent obtained from patient or acceptable surrogate
You will not qualify if you...
- Received intravenous thrombolysis prior to randomization
- Allergy to tenecteplase
- Seizures or neurological/mental illness at stroke onset preventing accurate baseline assessment
- Planned mechanical thrombectomy or other endovascular treatments
- Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
- Acute intracerebral hemorrhage or suspected subarachnoid hemorrhage
- Occlusions in multiple vascular territories
- Contraindications to MRI or CT with contrast
- Known bleeding disorders or recent use of anticoagulants with elevated INR
- Low platelets, abnormal coagulation tests, or extreme blood glucose levels
- Severe kidney failure or dialysis requirement
- Active internal bleeding or recent major bleeding events or surgeries
- Recent ischemic stroke, heart attack, brain injury, or brain surgery
- Life expectancy less than 1 year
- Inability to adhere to trial protocol or follow-up
- Participation in other clinical trials
- Pregnant or lactating women
- Any other condition that may pose hazards or affect participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Actively Recruiting
Research Team
W
Wei Hu, MD, PhD
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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