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Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO

NCT06910163 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-04-04

No results posted yet for this study

Summary

Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.

Conditions

  • Acute Stroke

Interventions

DIAGNOSTIC_TEST

Diagnostic standard of care

Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.

DIAGNOSTIC_TEST

LVOne Test

Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.

Sponsors & Collaborators

  • University of Puerto Rico

    collaborator OTHER

  • Mennonite Health System

    collaborator UNKNOWN

  • Juan Vicenty

    lead OTHER

Principal Investigators

  • Juan C Vicenty Padilla, MD · University of Puerto Rico Medical Sciences Campus

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06910163 on ClinicalTrials.gov