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

October 10, 2023 updated by: Adnan H. Siddiqui, University at Buffalo
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The neurological thrombectomy device is an investigational device

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer Gay, CCRP
  • Phone Number: 7164404231
  • Email: jgay@ubns.com

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • kaledia Health/Buffalo General Medical Center/GVI
        • Principal Investigator:
          • Adnan Siddiqui, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neurological thrombectomy device
Revascularization device is an investigational device.
Device: neurological thrombectomy device is an investigational device.
Revascularization device is an investigational device.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate technical efficacy outcomes with radiographical measurements
Time Frame: Day 3
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
Day 3
Evaluate technical efficacy outcomes with radiographical measurements
Time Frame: 90 days
The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University at Buffalo

Collaborators

University at Buffalo Jacobs Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D001-PRT21-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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