Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator

CoAxia22 enrolled

Overview

To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke

Interventions

NeuroFlo catheterDEVICE

NeuroFlo™ catheter 45 minute treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ischemic stroke * NIHSS between 5-22 * Persistent clinical deficits following administration of rt-PA Exclusion Criteria: * Planned thrombectomy * Aortic pathology * Severe heart disease * Other conditions the doctor will assess

Locations (4)

University of Alberta

Edmonton, Alberta, Canada

University of Western Ontario

London, Ontario, Canada

Trillium Health Centre

Mississauga, Ontario, Canada

University of Erlangen

Erlangen, Germany

Outcomes

Primary Outcomes

An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.

Time frame: Baseline to 30 days post-treatment

Secondary Outcomes

Potential patient benefit will be assessed through collection of neurological indices.

Time frame: Baseline through 90 days

Data from ClinicalTrials.gov

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