WithdrawnNot Applicable

Study on the Efficacy and Safety of T-02 for the Treatment for Acute Ischemic Stroke

Stopped: Change of business strategy of Sponsor

0Started 2022-04-22

Plain-language summary

To examine the revascularization efficacy and safety of T-02 and its associated performance characteristics in treatment of appropriately selected subjects experiencing an acute ischemic stroke when the treatment is initiated within 24 hours after last seen well under the current guideline, and to generate hypotheses to be confirmed in subsequent confirmatory clinical investigations

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
✓. Subject can be treated within 24 hours after time last seen well (TLSW)
✓. Subject belongs to one of the following subgroups:
✓. Subject has received IV t-PA therapy; or
✓. Subject is contraindicated for IV t-PA administration
✓. Baseline NIHSS ≥6
✓. No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
✓. Age ≥18

What they're measuring

eTICI 2b-3

Timeframe: immediately after the intervention

sICH

Timeframe: within 24 hours

Trial details

NCT IDNCT05342038

SponsorBiomedical Solutions Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-31

View on ClinicalTrials.gov More Acute Ischemic Stroke trials