About this trial
The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
Presenting beyond 24 hours from last known well;
Ischemic stroke confirmed by head CT or MRI;
Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
Disqualifiers
None
Trial population
Acute stroke patients with large vessel occlusion and presenting beyond 24 hours from last known well
Trial design
Cohort
Prospective
Treatments tested in this trial
Mechanical Thrombectomy
Procedure/SurgeryMechanical Thrombectomy: A stroke treatment method involving the use of a device to extract a blood clot from the blood vessels, restoring blood flow and reducing brain damage. Ischemic Post-conditioning: After thrombectomy, a procedure involving inflating and deflating a balloon in situ for four cycles of 2 minutes each, reducing reperfusion injury and minimizing neural damage. Selective Hypothermia: Administering cold saline either intra-arterially or within the cerebral sinus to lower brain temperature, mitigating ischemia-induced injury.
Treatment groups
Trial outcomes
Primary outcomes
Modified ranking scale (mRS) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
symptomatic intracranial hemorrhage
any hemorrhagic transformation on subsequent imaging associated with a neurological decline of at least 4 points increase on the NIHSS score
Secondary outcomes
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Occurrence of periprocedural complications
Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.
EuroQol five dimensions questionnaire (EQ-5D)
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Sponsors and contacts
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