New Stent Retriever, VERSI System for AIS

Kobe City General Hospital

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03366818

NEURO0001

Details and patient eligibility

About

To confirm efficacy and safety of VERSI system for acute ischemic stroke

Full description

Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• onset to treat within 8 hours
• NIHSS 8 or more
• ASPECTS 5 or more
• Target vessel is ICA, MCA, VA, BA, PCA
• non-eligible or failed IV rt-PA

Exclusion criteria

• known hemorrhagic tendency
• arterial dissection, vasculitis
• allergy for contrast media
• other inappropriate condition

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

thrombectomy

Experimental group

Description:

thrombectomy by Versi system

Treatment:

Device: thrombectomy