A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT (NCT05198323)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1).
3. Subject has an NIHSS ≥6.
4. Subject is eligible to be treated with EVT within 24 hours after stroke symptoms onset. Subject has no severe contrast allergy or absolute contraindication to iodinated contrast preventing EVT, including any contraindications listed in the prescribing information approved by local regulatory authorities.
5. Subject is able to receive the investigational product before EVT and within 24 hours after stroke symptoms onset.
6. Subjects who are women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after dosing of investigational product. Neuroimaging Inclusion Criteria:
7. Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
8. Subject is confirmed to have a symptomatic intracranial occlusion, based on magnetic resonance angiography (MRA)/computed tomography angiography (CTA) \* , at the following location: M1 middle cerebral artery (MCA), which is before bifurcation of M2. Functionally, when defining the M1 MCA, the bulk of the MCA territory must be ischemic. \* Only an intracranial MRA is required for subjects screened with MRA; cervical MRA is not required. Cervical and intracranial CTAs are typically obtained simultaneously in subjects screened with CTA, but only the intracranial CTA is required for enrollment.
9. Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio \>1.2 \*\* .
10. The mismatch ratio is determined by the RAPID software in real time based on the difference between the ischemic core lesion volume and the time-to-maximum (Tmax) \>6s lesion volume. If both a multimodal MRI and CTP are performed before enrollment, the later of the 2 scans is assessed to determine eligibility. \[Alternative Neuroimaging Inclusion Criteria\]
11. If MRA/CTA is technically inadequate: Tmax \>6s perfusion deficit consistent with M1 MCA occlusion AND Target Mismatch Profile with ischemic core volume ≤70 mL, mismatch ratio \>1.2 as determined by RAPID software.
12. If magnetic resonance perfusion (MRP) is technically inadequate: M1 MCA occlusion by MRA/CTA AND Diffusion Weighted Imaging (DWI) volume \<25 mL

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

• CHI Memorial Hospital — Chattanooga, Tennessee
• Taichung Medical University — Taichung,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.