Acute Ischemic Stroke Stroke
Conditions
Interventions
Sponsors
Or-nim Medical Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients presenting with anterior circulation ischemic stroke syndrome 2. Patients meeting the eligibility criteria for IV rt-PA and/ or EVT 3. Patients undergoing pre-treatment vascular imaging as part of their stroke evaluation;CTA/MRA 4. Baseline CTA or MRA confirming the presence of an anterior circulation arterial proximal occlusion (ACA, MCA including M1 or M2, or ICA) 5. Age *18 years 6. Informed consent is obtained from the subject or his/her representative (deferred consent).
Exclusion criteria
Exclusion criteria: 1. Posterior circulation stroke 2. Absolute contraindications for CTA, MRA, or DSA 3. Lacerations or skin defects at the forehead area where sensors should be placed 4. Brain CT-scan (or MRI) showing hemorrhage 5. Investigator determination that subject is not a potential candidate for an endovascular. intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective 1: the sensitivity and specificity of C-FLOW measurements in detecting regional changes in CBF, perfusion, and recanalization status compared with CTA or MRA using the modified Arterial Occlusive Lesion (mAOL) score, or DSA using the Thrombolysis In Cerebral Infarction (TICI) score. Objective 2: the feasibility, tolerability, and safety of C-FLOW monitoring will be assessed using the following measures 1) Assessment of the feasibility of C-FLOW monitoring will be based on the number of patients who complete >75% of the monitoring period with a good quality of signal. We will use the signal quality algorithm to evaluate the quality of signals during monitoring. The C-FLOW signals will be evaluated off line using an automatic algorithm based on machine learning that produces a general quality score of each probe & an evaluation of the duration of low quality signals. 2) Safety of the device will be assessed by the incidence of device related AEs and SAEs. 3) Tolerability will be assessed by the number of patients who are unable to complete the full monitoring period due to device intolerability, for example due to skin irritation, discomfort, or pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate changes in C-FLOW in comparison to clinical improvement will be defined as a reduction of NIHSS score *10 points compared to baseline, or NIHSS *3. 2. Evaluate changes in C-FLOW in comparison to Modified Rankin Scale score at 90-days will be dichotomized to define good outcome as mRS *2. We will also determine the overall distribution of scores on mRS. | — |
Countries
Netherlands, Spain, United States of America
Outcome results
None listed