Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05685043 |
Other study ID # |
BC-11282 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2023 |
Est. completion date |
July 1, 2027 |
Study information
Verified date |
May 2023 |
Source |
University Hospital, Ghent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Ischemic stroke is a major cause of death or residual disability. It is caused by a blood
clot blocking the brain arterial blood flow. Resolution of this blood clot can be achieved by
intravenous injection of a blood clot resolving medication, if done within 4,5 h after the
onset of complaints. Since about ten years, a supplementary treatment, known as mechanical
thrombectomy, can be used to retrieve the blood clot from the brain circulation using a
stent-retrieving system. This procedure requires an invasive transarterial approach and
placement of tubes (catheter-systems) in the main brain supplying arteries to retrieve the
clot by deploying stent-retrievers or by aspiration. After this maneuver, the blood supply of
the brain is restored and the brain tissue that was at risk for infarction can recover.
Mechanical thrombectomy has been proven to improve the functional independence of patients
significantly, compared to best medical treatment alone, when performed within 6 hours of
symptom onset (46% vs 26,5%).
Studies emerged on patients arriving late in the hospital, more than 6 h after onset, where
mechanical thrombectomy was only performed on selected patients. Selection was based on
perfusion CT scan results, which demonstrate infarction and surrounding tissue at risk
(penumbra).
The functional independence was significantly better in patients who received mechanical
thrombectomy versus those who only got best medical support.
In this trial the investigators aim to investigate whether the application of perfusion CT
criteria to select or exclude patients from mechanical thrombectomy is non-inferior to
mechanical thrombectomy without selection, with respect to functional independence at 90 days
(mRS score of 0 to 2), in patients with an acute ischemic stroke caused by an occlusion of a
major vessel in the anterior cerebral circulation, treated within 6 hours of symptom onset.