Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator (FASTFlo tPA)

CoAxia

Status and phase: Completed; Phase 1

Conditions: Ischemic Stroke

Treatments: Device: NeuroFlo catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006993

CD-0258

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

NeuroFlo Treatment

Experimental group

Treatment:

Device: NeuroFlo catheter