Text Size

Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients (Flo 24)

This study has been completed.
Sponsor:
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT00436592
First received: February 16, 2007
Last updated: February 3, 2009
Last verified: February 2009
History of Changes

February 16, 2007
February 3, 2009
February 2007
January 2009   (final data collection date for primary outcome measure)
Assessment of all adverse events from baseline to 30 days post-treatment. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
The primary safety endpoint for this study will be an assessment of all adverse events occurring from baseline to 30 days post-treatment.
Complete list of historical versions of study NCT00436592 on ClinicalTrials.gov Archive Site
  • Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
  • Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure. [ Time Frame: ≤ 4 hours ] [ Designated as safety issue: No ]
  • Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
  • Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
Not Provided
Not Provided
 
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebrovascular Accident
Device: NeuroFlo™ Catheter
45 minute Treatment
Experimental: 1
Intervention: Device: NeuroFlo™ Catheter
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Switzerland
 
NCT00436592
CD-0240
Yes
Flo 24 Steering Committee, CoAxia
CoAxia
Not Provided
Study Chair: Flo 24 Steering Committee Multiple Organizations
CoAxia
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP