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NCT05074186 Clinical Trial

Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05074186
Other study ID # D001-PRT21-026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date January 31, 2025

Study information
Verified date October 2023
Source University at Buffalo
Contact Jennifer Gay, CCRP
Phone 7164404231
Email jgay@ubns.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients

Description:

The neurological thrombectomy device is an investigational device

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date January 31, 2025
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) = 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN); Exclusion Criteria: Cannot provide consent or legally authorized representative not available to provide consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• neurological thrombectomy device is an investigational device.
Revascularization device is an investigational device.

Locations
Country Name City State
United States kaledia Health/Buffalo General Medical Center/GVI Buffalo New York

Sponsors (2)
Lead Sponsor Collaborator
University at Buffalo University at Buffalo Jacobs Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate technical efficacy outcomes with radiographical measurements The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score Day 1
Primary outcomes with radiographical measurements The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score day 1
Secondary Evaluate technical efficacy outcomes with radiographical measurements The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score Day 3
Secondary Evaluate technical efficacy outcomes with radiographical measurements The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score 90 days
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