Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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 stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.

Key facts

Study ID

NCT00419705

Run by

PhotoThera, Inc

People needed

660

Starts

2006-12-01

Expected to finish

2008-07-01

Last updated by the study team

2011-06-09

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• >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)

Where it is running

• Alta Bates Summit Medical Center — Berkeley, California, United States
• Scripps Encinitas Hospital — Encinitas, California, United States
• Grossmont Hospital — La Mesa, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Tri City Medical Center — Oceanside, California, United States
• Stanford Hospital and Clinics — Palo Alto, California, United States
• Sharp Healthcare — San Diego, California, United States
• Neurology Medical Group of Diablo Valley — Walnut Creek, California, United States
• Swedish Medical Center — Englewood, Colorado, United States
• The Stroke Center at Hartford Hospital — Hartford, Connecticut, United States
• North Broward Medical Center — Deerfield Beach, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Health First Holmes Regional Medical Center — Melbourne, Florida, United States
• Naples Community Hospital — Naples, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Fawcett Memorial Hospital — Port Charlotte, Florida, United States
• Dekalb Medical Center — Decatur, Georgia, United States
• Dekalb Neurology Associates LLC — Decatur, Georgia, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• Intensive Care Unit, Northwestern Memorial Hospital — Chicago, Illinois, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Sparks Regional Medical Center — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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