Status:
COMPLETED
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
Lead Sponsor:
PhotoThera, Inc
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief Summary
The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic s...
Detailed Description
This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days pos...
Eligibility Criteria
Inclusion
- Diagnosis of Acute Ischemic Stroke within 24 hours
- Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
- NIHSS ≥7 - ≤22
Exclusion
- \>24hours from symptom onset to time of treatment
- Evidence of intracranial, subdural, or subarachnoid hemorrhage
- Clinical presentation of intracranial hemorrhage
- Pre stroke ≥3 mRS
- The presence of a brainstem or cerebellar stroke
- Transient Ischemic Attack (TIA)
- Seizure at stroke onset
- Blood glucose \>400 or \<60
- Sustained systolic BP \>220mmHG \< 80mmHG or diastolic \>140mmHG \<50mmHG
- Septic embolus
- CNS tumor (except asymptomatic meningioma)
- Dermatologic condition of the scalp (e.g. Psoriasis)
- Thrombolytic therapy
- Head implant (e.g. Clipped aneurysm, Hakim valve)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00419705
Start Date
December 1 2006
End Date
July 1 2008
Last Update
June 9 2011
Active Locations (58)
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1
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
2
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705
3
Scripps Encinitas Hospital
Encinitas, California, United States, 92024
4
Grossmont Hospital
La Mesa, California, United States, 91942