PHOTOTHERA LASER SYSTEM FEASIBILITY ASSESSMENT

Not Applicable

• Conditions: -I64 Stroke, not specified as haemorrhage or infarction; Stroke, not specified as haemorrhage or infarction; I64

• Registration Number: PER-016-04
• Lead Sponsor: PHOTOTHERA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-04-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

The Subject is at least 40 years old at the time of detection, but has not reached his 85th birthday.
The Subject suffers from acute ischemic stroke.
Possibility of starting treatment with photothera laser system within 24 hours of the start of the ACV
The subject and / or his / her legal representative give their informed consent before taking the study.
The Subject wishes to participate in this study for at least 3 months after the start of the ACV.

Exclusion Criteria

The Subject has been presented to the Community hospital more than 24 hours after the start of the ACV.
Evidence of intracranial, subdural or subarachnoid hemorrhage in the CT scan
The subject is a candidate for intravenous administration of tissue plasminogen activator (tPA) for the treatment of acute ischemic stroke and is administered tPA.
The Subject had convulsions at the beginning of the ACV.
Serum glucose greater than 400 mg / dL or less than 40 mg / dL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Global Evolution Scale<br>Measure:The average percentage change of the Global Evolution Scale from baseline to 90 days.<br>Timepoints:90 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:survival<br>Measure:Period of free survival of adverse events related to the procedure in 3 months<br>Timepoints:3 month<br>