NCT01006993

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 11, 2010

Status Verified

March 1, 2010

Enrollment Period

2.2 years

First QC Date

November 2, 2009

Last Update Submit

March 10, 2010

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

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

    Baseline to 30 days post-treatment

Secondary Outcomes (1)

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

    Baseline through 90 days

Study Arms (1)

NeuroFlo Treatment

EXPERIMENTAL
Device: NeuroFlo catheter

Interventions

NeuroFlo catheterDEVICE

NeuroFlo™ catheter 45 minute treatment

NeuroFlo Treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke
  • NIHSS between 5-22
  • Persistent clinical deficits following administration of rt-PA

You may not qualify if:

  • Planned thrombectomy
  • Aortic pathology
  • Severe heart disease
  • Other conditions the doctor will assess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 4A2, Canada

Location

University of Erlangen

Erlangen, 91054, Germany

Location

Related Publications (1)

  • Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.

    PMID: 21350210DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • FASTFlo Steering Committee

    Various

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

May 1, 2007

Primary Completion

July 1, 2009

Study Completion

January 1, 2010

Last Updated

March 11, 2010

Record last verified: 2010-03

Locations

DE(1)CA(3)