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

C

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)

22 participants in 1 patient group

NeuroFlo Treatment
Experimental group
Treatment:
Device: NeuroFlo catheter

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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