Actively Recruiting
A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
Led by Lumosa Therapeutics Co., Ltd. · Updated on 2025-06-05
66
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT).
CONDITIONS
Official Title
A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legal representative consents after full study information
- Aged 18 to 90 years at screening
- NIH Stroke Scale score of 6 or higher
- Eligible for endovascular thrombectomy within 24 hours of stroke symptom onset
- No severe allergy or contraindication to iodinated contrast
- Able to receive study drug before thrombectomy and within 24 hours of stroke onset
- Women of childbearing potential and men with partners of childbearing potential agree to use effective contraception during study and for 3 months after dosing
- Able to undergo contrast brain perfusion MRI or CT
- Confirmed symptomatic intracranial occlusion at M1 middle cerebral artery before M2 bifurcation
- Target mismatch profile on MRI or CT perfusion with ischemic core volume 70 mL or less and mismatch ratio over 1.2
- Alternative imaging criteria if primary imaging is inadequate
You will not qualify if you...
- Treated or intended to treat with intravenous thrombolytic during current stroke
- Treated with endovascular thrombectomy before study drug in current stroke
- Pre-stroke disability requiring help with daily living (mRS 2 or higher)
- Large ischemic core volume over 70 mL or ASPECTS score 5 or less
- Symptoms suggesting subarachnoid hemorrhage
- Imaging showing acute intracranial hemorrhage, tumor (except small meningioma), vascular malformations, CNS lesions increasing bleeding risk, or aneurysm needing treatment
- Significant brain swelling with midline shift
- Intracranial stent in same vascular area preventing safe thrombectomy device use
- Medical, neurological, or psychiatric diseases confounding evaluations (e.g., seizures at stroke onset, dementia)
- Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg) before dosing
- Bleeding disorders, coagulation factor deficiency, or recent oral anticoagulant therapy with high INR or aPTT
- Use of new oral anticoagulants within 48 hours before treatment
- Low platelet count (<100,000/mm3)
- Low hemoglobin (<7 mmol/L)
- Abnormal sodium or potassium levels
- Blood glucose below 50 mg/dL or above 400 mg/dL
- Severe liver, kidney, or active infection
- Pregnant, lactating, or planning pregnancy during study
- Prior stroke, heart attack, or serious head injury within 90 days
- History of intracranial hemorrhage within 90 days
- Major surgery within 90 days
- Recent bleeding events within 21 days
- Recent puncture of noncompressible vessels within 7 days
- Participation in another investigational study with recent investigational product use
- Investigator judgment excluding for EVT procedure risks or other serious illnesses preventing follow-up or improvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CHI Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
2
Taichung Medical University
Taichung, Taiwan
Actively Recruiting
Research Team
C
Claire Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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