Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients (Flo 24)
This study has been completed.
Sponsor:
CoAxia
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT00436592
First received: February 16, 2007
Last updated: February 3, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Device: NeuroFlo™ Catheter |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients |
Further study details as provided by CoAxia:
Primary Outcome Measures:
- Assessment of all adverse events from baseline to 30 days post-treatment. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 26 |
| Study Start Date: | February 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: NeuroFlo™ Catheter
45 minute Treatment
|
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436592
Locations
| United States, California | |
| UCLA | |
| Los Angeles, California, United States, 90024 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Germany | |
| University of Erlangen | |
| Erlangen, Germany | |
| University of Essen | |
| Essen, Germany | |
| Switzerland | |
| CHUV Lausanne | |
| Lausanne, Switzerland | |
Sponsors and Collaborators
CoAxia
Investigators
| Study Chair: | Flo 24 Steering Committee | Multiple Organizations |
More Information
Additional Information:
No publications provided by CoAxia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Flo 24 Steering Committee, CoAxia |
| ClinicalTrials.gov Identifier: | NCT00436592 History of Changes |
| Other Study ID Numbers: | CD-0240 |
| Study First Received: | February 16, 2007 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by CoAxia:
|
acute ischemic stroke device treatment |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013