Toro88 Aspiration Study for Acute Ischemic Stroke

A First-in-Human, Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke - TORO EFFECT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052240160

Enrollment

Registered

2024-10-15

Start date

2024-11-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke ischemic stroke, large vessel occlusion

Interventions

endovascular treatment

endovascular treatment, mechanical thrombectomy, aspiration therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 acute icshemic stroke 2 ICA/M1/VA/BA occlusion (eTICI 0 or 1) 3 used study device for ist pass 4 age 18 to 90 5 obtain donumented consent and agreement

Exclusion criteria

Exclusion criteria: 1 arterial dissection, arterites or atherosclerotic disease 2 50% or more stenosis at proximal 3 target artery diameter is 2mm or smaller 4 associate intracranial hemorrhage, known hemorrhagic disease, known coaglation disorder, PT-INR 3.0 or more, APTT 2 times or more with mormal range 5 sBP 180mmHg or more, dBP 110mmHg or more, uncontrolable 6 BS 50mg/dL or less 7 severe allegy for contrast 8 2 or more majoe territory occlusion, R-ICA, L-ICA and VABA 9 90 days follow up is impossible 10 candidate for other clinical trial 11 inapropriate candidate decide by investigator

Design outcomes

Primary

Measure	Time frame
Efficacy; Successful recanalization (eTICI 2b50 or better, upto 3 passes) Safety; Device related or relation suspected adverse event within 7 (-2/+3) days after procedure, espcially distal embolization, symptomatic dissection, vasospasm, and perforation, hemorrgaic stroke	—

Secondary

Measure	Time frame
1. technical sucess 2. first pass effect (eTICI 2c or better) 3. successful recanalization (eTICI 2b50 or better) 4. successful recanalization (eTICI 2n67 ore better) 5. symptomatic intracranial hemorrhage within 24 hours (NIHSS 4 or more worsened) 6. Device related adverse event within 7 (-2/+3) days after procedure, espcially distal embolization, symptomatic dissection, vasospasm, and perforation, hemorrgaic stroke 7. any adverse event within 7days 8. mRS at 7days after procedure 9. any secere adverse event within 90days 10. mortality within 90days 11. mRS at 90days after procedure	—

Measure

Time frame

1. technical sucess 2. first pass effect (eTICI 2c or better) 3. successful recanalization (eTICI 2b50 or better) 4. successful recanalization (eTICI 2n67 ore better) 5. symptomatic intracranial hemorrhage within 24 hours (NIHSS 4 or more worsened) 6. Device related adverse event within 7 (-2/+3) days after procedure, espcially distal embolization, symptomatic dissection, vasospasm, and perforation, hemorrgaic stroke 7. any adverse event within 7days 8. mRS at 7days after procedure 9. any secere adverse event within 90days 10. mortality within 90days 11. mRS at 90days after procedure

—

Contacts

Public ContactYuriko Watabe

Institute of Kyoto Medical Research

t_toro@shimizu-hospital.or.jp+81-75-381-5161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026