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Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

2014-08-27 03:13:48 | BioPortfolio

Summary

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Ischemic Stroke

Intervention

NeuroThera® Laser System

Location

University of Alabama Birmingham
Birmingham
Alabama
United States
35294

Status

Recruiting

Source

PhotoThera, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:48-0400

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Medical and Biotech [MESH] Definitions

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

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A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.

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