An observational study in Acute Ischemic Stroke and Large Vessel Occlusion, sponsored by Zhongshan Hospital Xiamen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Zhongshan Hospital Xiamen University · Observational
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:
Participants will:
The study will not delay or change standard stroke treatment.
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.
Exclusion Criteria:
Adults 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.
Other: Prospective Mechanical Thrombectomy Cohort
Adults 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.
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.
Time frame: During mechanical thrombectomy, before recanalization
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.
Time frame: During mechanical thrombectomy, before recanalization
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.
Time frame: During mechanical thrombectomy, before recanalization
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.
Time frame: During mechanical thrombectomy, before recanalization
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.
Time frame: During mechanical thrombectomy, before recanalization
Trans-Thrombus Malondialdehyde Gradient
The primary outcome is the within-participant trans-thrombus Malondialdehyde gradient, defined as ln\[T2b/T2a\], where T2b is the Malondialdehyde concentration in arterial plasma collected distal to the thrombus and T2a is the Malondialdehyde concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
Trans-Thrombus Matrix Metalloproteinase-9 Gradient
The primary outcome is the within-participant trans-thrombus Matrix Metalloproteinase-9 gradient, defined as ln\[T2b/T2a\], where T2b is the Matrix Metalloproteinase-9 concentration in arterial plasma collected distal to the thrombus and T2a is the Matrix Metalloproteinase-9 concentration in arterial plasma collected proximal to the thrombus.
Time frame: During mechanical thrombectomy, before recanalization
Modified Rankin Score
The ordinal distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death).
Time frame: 90 (±14) days
Functional independence
The proportion of mRS score of 0-2 at 90 days.
Time frame: 90 (±14) days
Good Function
The proportion of mRS score of 0-3 at 90 days.
Time frame: 90 (±14) days
Early neurological improvement
The proportion of NIHSS 0-1 or ≥4 points reduction at 24 (±12) hours.
Time frame: 24 (±12) hours
Change in stroke severity
The change of NIHSS score from baseline to 7 days or at discharge (whichever comes first)
Time frame: 7 (±1) days or at discharge
Quality of life measured by EQ-5D-5L
EQ-5D-5L scale score at 90 days.
Time frame: 90 (±14) days
Symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage within 36 hours from randomization (Heidelberg criteria)
Time frame: 24 (±12) hours
Any intracranial hemorrhage
Incidence of any intracranial hemorrhage within 36 hours from randomization (Heidelberg classification)
Time frame: 24 (±12) hours
Extracranial bleeding
Incidence of moderate-to-severe extracranial bleeding (GUSTO criteria) within 36 hours from randomization
Time frame: 24 (±12) hours
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
Time frame: 7 (±1) days or at discharge
Mortality
All cause death within 90 days.
Time frame: 90 days
Modified Rankin Score
The ordinal distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death).
Time frame: 1 year
Plan to share: No — Individual participant data, including clinical and biospecimen data, will not be publicly shared because of ethical, privacy, informed-consent, and institutional restrictions. Requests for access to de-identified data for scientifically valid purposes may be considered by the principal investigator and the institution, subject to applicable ethics approval and a data-use agreement. Contact: Xingyu Chen, 2005chenxingyu@163.com
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Zhongshan Hospital Xiamen University