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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

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