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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: neurological thrombectomy device is an investigational device.

• Registration Number: NCT05074186
• Lead Sponsor: University at Buffalo

Brief 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

Detailed Description

The neurological thrombectomy device is an investigational device

Study Timeline

• Study Start: 2021-06-08
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neurological thrombectomy device	neurological thrombectomy device is an investigational device.	Revascularization device is an investigational device.

Primary Outcome Measures

Name	Time	Method
Evaluate technical efficacy outcomes with radiographical measurements	Day 1	The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
outcomes with radiographical measurements	day 1	The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

Secondary Outcome Measures

Name	Time	Method
Evaluate technical efficacy outcomes with radiographical measurements	90 days	The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score

Trial Locations

Locations (1)

kaledia Health/Buffalo General Medical Center/GVI; 🇺🇸 Buffalo, New York, United States