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

Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006993

Acronym

FASTFlo tPA

Enrollment

Registered

2009-11-03

Start date

2007-05-31

Completion date

2010-01-31

Last updated

2010-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief summary

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

Interventions

DEVICENeuroFlo catheter

NeuroFlo™ catheter 45 minute treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.	Baseline to 30 days post-treatment

Secondary

Measure	Time frame
Potential patient benefit will be assessed through collection of neurological indices.	Baseline through 90 days

Countries

Canada, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026