New Stent Retriever, VERSI System for AIS

Acute Ischemic Stroke Clinical Trial

Official title:

Efficacy and Safety of VERSI System for Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366818
• Other study ID #: NEURO0001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2019
• Source: Kobe City General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Device:
• thrombectomy
mechanical thrombectomy

Locations

Country	Name	City	State
Japan	Kobe City General Hospital	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe City General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of treatment-related severe adverse event	symptomatic intracranial hemorrhage	within 24 hours after procedure
Secondary	recovery to independent life {modified Rankin score of 2 or less]	Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less	90days after procedure
Secondary	all intracralnial hemorrhage	incidence of symptomatic and asymptomatic intracranial hemorrhage	within 24 hours after procedure
Secondary	acceptable clinical outcome	Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS	90days after procedure
Secondary	Severe adverse event related to device	Any severe adverse event related to device	within 24 hours after procedure
Secondary	recanalization ability of device	rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater	immediatry after procedure