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

Jacobs institute

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: neurological thrombectomy device is an investigational device.

Study type: Interventional

Funder types: Other

Identifiers

NCT05074186

DELPHI D001-PRT21-026

Details and patient eligibility

About

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

Full description

The neurological thrombectomy device is an investigational device

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

neurological thrombectomy device

Experimental group

Description:

Revascularization device is an investigational device.

Treatment:

Device: neurological thrombectomy device is an investigational device.