Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients (Flo 24)

CoAxia

Status and phase: Completed; Phase 1

Conditions: Cerebrovascular Accident

Treatments: Device: NeuroFlo™ Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436592

CD-0240

Details and patient eligibility

About

The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

Full description

The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.

A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian & European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic stroke
• NIHSS between 4-20
• Time from symptom onset between 8 and 24 hours

Exclusion criteria

• Hemorrhagic stroke
• Certain types of heart disease
• Kidney 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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26 participants in 1 patient group

1

Experimental group

Treatment:

Device: NeuroFlo™ Catheter