Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke

Terminated

• Conditions: Stroke; Acute Ischemic Stroke
• Interventions: Device: NovaGuide 2 Intelligent Ultrasound System

• Registration Number: NCT05547412
• Lead Sponsor: NovaSignal Corp.

Brief Summary

This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.

Detailed Description

The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-16
• Study Start: 2022-09-21
• Study First Posted: 2022-09-21
• Primary Completion: 2023-01-16
• Study Completion: 2023-01-31
• Results First Submitted: 2024-02-06
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Results First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Subject aged 18 years and older referred for evaluation of possible stroke.
2. Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke.
3. Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

Exclusion Criteria

1. Head CT findings consistent with acute primary intracranial hemorrhage (ICH), etc.
2. Subjects with occlusions in the distal or posterior circulation arteries.
3. Subjects who underwent partial or full craniotomy
4. Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
5. Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
6. Subjects who have a physical limitation preventing placement of the system.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	NovaGuide 2 Intelligent Ultrasound System	Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2
Cohort A	NovaGuide 2 Intelligent Ultrasound System	Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2
Cohort X	NovaGuide 2 Intelligent Ultrasound System	Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.	1 day	The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2.

Trial Locations

Locations (1)

CHI Memorial Hospital; 🇺🇸 Chattanooga, Tennessee, United States