PHOTO THERA LASER SYSTEM FEASIBILITY ASSESSMENT

Not Applicable

• Conditions: -I669 Occlusion and stenosis of unspecified cerebral artery; Occlusion and stenosis of unspecified cerebral artery; I669

• Registration Number: PER-043-05
• Lead Sponsor: PHOTOTHERA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. The Subject is at least 40 years old and under 86 years old.
2. The Subject suffers from acute ischemic stroke and presents to the community hospital within the first 24 hours of onset.
3. Possibility of starting treatment with NTS within 24 hours of the start of the ACV.
4. Clinical diagnosis of ischemic stroke as a cause of measurable neurological deficit.
5. Total score in the detection of> 7 and <22 on the NIH ACV Scale evaluated at the time of admission to the Community Hospital.
6. The subject and / or his / her legal representative give their informed consent before taking the study.
7. The Subject wishes to participate in this study for at least 3 months after the start of the ACV.
8. It is the opinion of the Principal Investigator, that based on the knowledge of the condition of the subject, as well as the characteristics of the NTS, that the subject is an appropriate candidate for the management of the LCA using an NTS.

Exclusion Criteria

1. The Subject has been presented to the Community hospital more than 24 hours after the start of the ACV.
2. Evidence of intracranial, subdural, or subarachnoid hemorrhage on CT or MRI.
3. The subject is a candidate for intravenous administration of tissue plasminogen activator (tPA) for the treatment of acute ischemic stroke and is administered tPA.
4. The Subject had convulsions at the beginning of the ACV.
5. Serum glucose greater than 400 mg / dL or less than 40 mg / dL.
6. Sustained hypertension.
7. Sustained hypotension.
8. Presumed septic plunger.
9. Hereditary or acquired acquired hemorrhagic diathesis.
10. The subject has an alteration of the skin in the chosen site for the application of infrared energy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Global Evolution Scale (GOS). The GOS is made up of the following four scales: NIH ACV Scale (NIHSS), Rankin Modified Scale (MRS), Glasgow Scale (GS) and Barthel Index (BI)<br>Measure:Evaluation of the effectiveness of the treatment<br>Timepoints:Before treatment, 24 hours post treatment, days 7, 30, 60 and 90<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Survival without adverse events: Clinical evaluation.<br>Tests of serum biochemistry, hemotology. 12-lead ECG.<br>Measure:Treatment safety<br>Timepoints:Clinical evaluation during visits: Before treatment, 24 hours post treatment, days 7, 30, 60 and 90.<br>Tests of serum biochemistry, hemotology. 12-lead ECG: Before the treatment and on day 90.<br>