Clinical trial NCT00436592: Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Official title: Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebrovascular Accident
Keywords: acute
ischemic
stroke
device
treatment
Lead sponsor: CoAxia
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of all adverse events from baseline to 30 days post-treatment.
timeFrame: 30 Days
Secondary outcomes:
measure: Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
timeFrame: 90 Days
measure: Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
timeFrame: ≤ 4 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Erlangen
country: Germany
facility: University of Erlangen
city: Essen
country: Germany
facility: University of Essen
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
Study officials:
affiliation: Multiple Organizations
name: Flo 24 Steering Committee
role: STUDY_CHAIR
References:
citation: Hammer MD, Schwamm L, Starkman S, Schellinger PD, Jovin T, Nogueira R, Burgin WS, Sen S, Diener HC, Watson T, Michel P, Shuaib A, Dillon W, Liebeskind DS. Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients. Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.