Toro88 Aspiration Study for Acute Ischemic Stroke

JRCT ID: jRCTs052240160

Registered date:15/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute ischemic stroke
• Date of first enrollment: 15/10/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): endovascular treatment

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakai Nobuyuki