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The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.
This is a multi-center, non-randomized observational study of acute ischemic stroke patients whose CTA scans are analyzed by Viz LVO to support clinicians in making stroke triage decisions,. The study results will be compared to a cohort from enrolling centers prior to Viz LVO implementation that will serve as a historical control. Data will be collected retrospectively from the time of presentation through 90 days post discharge.
The study will include patients undergoing imaging for a suspected LVO acute ischemic stroke. The post-Viz LVO intervention group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, following image analysis by Viz LVO. Data will be collected retrospectively on consecutive patients meeting eligibility criteria from the date of implementation up to 5 years post implementation.
The control group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, for evaluation prior to the implementation of Viz LVO. Data will be collected on consecutive patients from one day prior to implementation, back as far as 2 years prior to implementation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Viz | Pre-Viz LVO implementation patient data utilized as a control data set |
| |
| Post-Viz | Patient data collected post-Viz LVO implementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viz LVO (De Novo Number DEN170073) | Device | Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application. |
| Measure | Description | Time Frame |
|---|---|---|
| Transfer patients: Time from spoke CT/CTA to door-out | Time in minutes from CT/CTA imaging to time leaving the spoke center | up to 1 day (1440 minutes) |
| Non-transfer patients: Time from Hub door to groin puncture | Time in minutes from arrival a hub center to start time of treatment | up to 1 day (1440 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from Spoke Door-In to Door-Out (DIDO) | Time in minutes from arrival at spoke hospital to departure to hub hospital | up to 1 day (1440 minutes) |
| Time from Spoke CT/CTA to Specialist Notification |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected LVO acute ischemic stroke indicated for mechanical thrombectomy
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Thomas Devlin | CHI Memorial | Principal Investigator |
| Dr. Ameer Hassan | Valley Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar Neurosurgery | Atlanta | Georgia | 30312 | United States | ||
| Semmes-Murphey |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline Effectiveness Cohort | Other | No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred. |
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Time in minutes from CT/CTA imaging to time an interventionalist was notified
| up to 1 day (1440 minutes) |
| Time from Spoke CT/CTA to Groin Puncture | Time in minutes from CT/CTA imaging to start time of treatment | up to 1 day (1440 minutes) |
| Time from Spoke Door to Groin Puncture | Time in minutes from departure to hub hospital to start time of treatment | up to 1 day (1440 minutes) |
| Length of ICU Stay/Total Length of Stay | Number of days in hospital in the ICU and the total number of days in hospital | Hospital admit to discharge, up to 30 days |
| Modified Rankin Scale (mRS) at Discharge and 90 Days | The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. A score of 0 is a patient with no residual symptoms. Scores increase with severity to 5 which equals severe disability. | 90 days |
| National Institutes of Health Stroke Scale (NIHSS) at Discharge | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity. | On date of discharge, up to 30 days |
| Patient Disposition at Discharge and 90 Days | Data will be collected on whether or not the patient was discharged to their home or another type of care facility, and where they are located 90 days post hospital discharge | 90 days |
| Memphis |
| Tennessee |
| 38120 |
| United States |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | United States |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |