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BELgian CT-perFUSion Study to Select Acute Stroke Patients for Thrombectomy

NCT05685043 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of this clinical trial is to test whether perfusion CT can be used as a selection tool in stroke patients with a major anterior circulation occlusion, to exclude patients from thrombectomy because of a predicted non-beneficial outcome, when treated within 6 hours of symptom onset.

Researchers will compare the experimental group, where mechanical thrombectomy is only performed when prespecified perfusion CT criteria are fulfilled, with the standard of care treatment group, where all patients will receive mechanical thrombectomy, to see if functional independence at 90 days is non-inferior.

Conditions

  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic

Interventions

DEVICE

perfusion CT

Patients are selected for thrombectomy based on perfusion CT criteria. When the results from the perfusion CT scan (analyzed by RAPID software) indicate a core infarct volume exceeding 70 ml in patients \< 80 years or 55 ml in patients \> 80 years, then treatment is limited to best medical treatment (intravenous fibrinolysis if applicable) and no mechanical thrombectomy will be performed. This is the current standard of care for patients treated more than 6 hour after onset.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Luc Defreyne, Prof. · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-04-01
Completion
2023-04-01
FDA Device
Yes

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Entities

Diseases

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 NCT05685043 on ClinicalTrials.gov