Back to resultsAssessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neurological thrombectomy device is an investigational device.
Sponsored by
About this trial
This is an interventional device feasibility trial for Ischemic Stroke
Eligibility Criteria
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
Sites / Locations
- kaledia Health/Buffalo General Medical Center/GVIRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neurological thrombectomy device
Arm Description
Revascularization device is an investigational device.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05074186
First Posted
September 29, 2021
Last Updated
October 10, 2023
Sponsor
University at Buffalo
Collaborators
University at Buffalo Jacobs Institute
1. Study Identification
Unique Protocol Identification Number
NCT05074186
Brief Title
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
Official Title
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
University at Buffalo Jacobs Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neurological thrombectomy device
Arm Type
Experimental
Arm Description
Revascularization device is an investigational device.
Intervention Type
Device
Intervention Name(s)
neurological thrombectomy device is an investigational device.
Intervention Description
Revascularization device is an investigational device.
Primary Outcome Measure Information:
Title
Evaluate technical efficacy outcomes with radiographical measurements
Description
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Time Frame
Day 1
Title
outcomes with radiographical measurements
Description
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Evaluate technical efficacy outcomes with radiographical measurements
Description
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Time Frame
Day 3
Title
Evaluate technical efficacy outcomes with radiographical measurements
Description
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Gay, CCRP
Phone
7164404231
Email
jgay@ubns.com
Facility Information:
Facility Name
kaledia Health/Buffalo General Medical Center/GVI
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Gay
Phone
716-440-4231
Email
jgay@ubns.com
First Name & Middle Initial & Last Name & Degree
Adnan Siddiqui, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke
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