Feasibility and Safety of NeuroFlo in Stroke Patients Rec... | NCT01006993

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

NCT01006993

Sponsor

CoAxia

Status

Completed

Last Update Posted

Mar 11, 2010Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Ischemic Stroke

Interventions

NeuroFlo catheter

Countries

Canada
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Nov 2, 2009

First Submission Date that Met QC Criteria

Nov 2, 2009

First Posted Date

Nov 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2010

Last Update Posted Date

Mar 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NeuroFlo Treatment	Experimental		Device: NeuroFlo catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuroFlo catheter	Device	NeuroFlo™ catheter 45 minute treatment	NeuroFlo Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
FASTFlo Steering Committee	Various	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2B7	Canada
University of Western Ontario

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21350210	Derived	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.

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases