NCT05299034

Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)

Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,173 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are: 1. To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection. 2. To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window. 3. To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in \>6h from the onset of symptoms. METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases 1. retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window. 2. validation of the models in a prospective study. Clinical, radiological and transport variables will be studied. Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multiparametric imaging	MR perfusion or multiparametric CT including NCCT, CTA and CTP
DIAGNOSTIC_TEST	Non contrast CT+CT angiography	NCCT+CTA

Timeline

• Start date: 2022-01-14
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-03-28
• Last updated: 2023-08-22

Locations

1 site across 1 country: Spain