About this trial
The goal of this observational study is to describe the local change in interleukin-6 (IL-6) across a blood clot in adults with acute ischemic stroke caused by anterior circulation large vessel occlusion who are undergoing mechanical thrombectomy.
The main questions it aims to answer are:
* Is the level of IL-6 different in arterial blood collected beyond the clot compared with arterial blood collected before the clot during mechanical thrombectomy? * Is the trans-thrombus IL-6 difference associated with functional independence 90 days after stroke and with complications related to reperfusion injury? There is no comparison group and no experimental treatment. Researchers will compare paired blood samples collected from opposite sides of the clot in the same participant. Blood collected from a peripheral vein at hospital admission will be used only as a supportive reference for systemic inflammation.
Participants will:
* Receive standard mechanical thrombectomy and stroke care determined by their treating clinical team. * Have small blood samples collected at planned time points, including paired arterial blood samples collected during the thrombectomy procedure. * Have clinical and imaging information collected from their medical records and have functional status assessed 90 days after stroke.
The study will not delay or change standard stroke treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Acute ischemic stroke caused by anterior circulation large vessel occlusion, confirmed by routine vascular imaging or digital subtraction angiography.
Undergoing clinically indicated mechanical thrombectomy according to routine clinical practice.
Provision of written informed consent by the participant or legally authorized representative, in accordance with local ethics requirements.
Disqualifiers
Posterior circulation large vessel occlusion.
Mechanical thrombectomy not performed.
Known active systemic infection, active malignancy, or chronic inflammatory/autoimmune disease requiring systemic immunosuppressive treatment, when these conditions are expected to substantially affect inflammatory biomarker measurements.
Pregnancy or breastfeeding, if required by the local ethics committee.
Trial population
This single-center prospective observational cohort will enroll consecutive adults with acute ischemic stroke due to anterior circulation large vessel occlusion who undergo clinically indicated mechanical thrombectomy. Participants receive standard stroke care determined by the treating clinical team; no experimental treatment is assigned. During thrombectomy, paired arterial plasma samples are collected from locations proximal and distal to the thrombus when technically feasible and without delaying or altering routine treatment. An admission peripheral venous blood sample is collected as a supportive reference for systemic inflammation. Clinical, imaging, procedural, laboratory, and 90-day follow-up data are collected prospectively.
Trial design
Cohort
Prospective
Treatments tested in this trial
Prospective Mechanical Thrombectomy Cohort
Other interventionAdults with acute ischemic stroke due to anterior circulation large vessel occlusion who undergo clinically indicated mechanical thrombectomy. All participants receive standard stroke care determined by the treating clinical team; no experimental intervention is assigned. Paired arterial blood samples are collected during thrombectomy from sites proximal and distal to the thrombus. A peripheral venous blood sample collected at hospital admission is used as a supportive systemic reference. Clinical, imaging, procedural, and 90-day functional outcome data are collected prospectively.
Treatment groups
Trial outcomes
Primary outcomes
Trans-Thrombus Interleukin-6 Gradient
The primary outcome is the within-participant trans-thrombus interleukin-6 (IL-6) gradient, defined as ln \[T2b/T2a\], where T2b is the IL-6 concentration in arterial plasma collected distal to the thrombus and T2a is the IL-6 concentration in arterial plasma collected proximal to the thrombus.
Secondary outcomes
Trans-Thrombus Interleukin-1 Beta Gradient
The primary outcome is the within-participant trans-thrombus Interleukin-1β gradient, defined as ln\[T2b/T2a\], where T2b is the Interleukin-1β concentration in arterial plasma collected distal to the thrombus and T2a is the Interleukin-1β concentration in arterial plasma collected proximal to the thrombus.
Trans-Thrombus Interleukin-17 Gradient
The primary outcome is the within-participant trans-thrombus Interleukin-17 gradient, defined as ln\[T2b/T2a\], where T2b is the Interleukin-17 concentration in arterial plasma collected distal to the thrombus and T2a is the Interleukin-17 concentration in arterial plasma collected proximal to the thrombus.
Trans-Thrombus Complement C3 Gradient
The primary outcome is the within-participant trans-thrombus Complement C3 gradient, defined as ln\[T2b/T2a\], where T2b is the Complement C3 concentration in arterial plasma collected distal to the thrombus and T2a is the Complement C3 concentration in arterial plasma collected proximal to the thrombus.
Trans-Thrombus Complement C5a Gradient
The primary outcome is the within-participant trans-thrombus Complement C5a gradient, defined as ln\[T2b/T2a\], where T2b is the Complement C5a concentration in arterial plasma collected distal to the thrombus and T2a is the Complement C5a concentration in arterial plasma collected proximal to the thrombus.
Other outcomes
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage within 36 hours from randomization (Heidelberg criteria)
Any intracranial hemorrhage
Incidence of any intracranial hemorrhage within 36 hours from randomization (Heidelberg classification)
Extracranial bleeding
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from randomization
Malignant Cerebral Edema
Cerebral edema causing substantial mass effect, defined by neurological deterioration with imaging evidence of space-occupying cerebral swelling and/or the requirement for decompressive hemicraniectomy
Sponsors and contacts
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