Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT05299034
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2022-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VESTA
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: