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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2024-07-30

Brief Summary

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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

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Detailed Description

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The neurological thrombectomy device is an investigational device

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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neurological thrombectomy device

Revascularization device is an investigational device.

Group Type EXPERIMENTAL

neurological thrombectomy device is an investigational device.

Intervention Type DEVICE

Revascularization device is an investigational device.

Interventions

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neurological thrombectomy device is an investigational device.

Revascularization device is an investigational device.

Intervention Type DEVICE

Eligibility Criteria

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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);