Status:
COMPLETED
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
Lead Sponsor:
CoAxia
Conditions:
Cerebrovascular Accident
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain a...
Detailed Description
The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will...
Eligibility Criteria
Inclusion
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
Exclusion
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT00119717
Start Date
June 1 2005
End Date
July 1 2010
Last Update
May 18 2011
Active Locations (72)
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1
Huntsville Hospital
Huntsville, Alabama, United States, 35801
2
UCLA
Los Angeles, California, United States, 90024
3
Good Samaritan Hospital
San Jose, California, United States, 95124
4
Morton Plant Hospital
Clearwater, Florida, United States, 33756