An observational study in Intracranial Large Vessel Occlusion and Ischemic Stroke, sponsored by Xuan Sun. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Xuan Sun · Observational
This study is a prospective, multicenter, observational cohort study using a real-world study design. The aim of this study is to compare functional and safety outcomes of intravascular recanalization therapy (with COSIS distal stent protection technology strategy as the core) combined with standard drug therapy in improving functional outcomes in patients with intracranial large vessel occlusion in the ultra late window (24 hours-30 days) compared with standard drug therapy alone.
Patients with ischemic stroke whose onset or last known well (LKW) ranged from 24 hours to 30 days, who were confirmed by imaging to have intracranial large vessel occlusion and may still have brain tissue that can be saved were included. The study did not interfere with the choice of treatment options. Patients received intravascular therapy or standard drug treatment, which was determined by clinicians according to the condition, imaging characteristics and the joint decision of doctors and patients. According to the actual treatment of patients, the intravascular treatment cohort and the standard drug treatment cohort were formed, in which the intravascular treatment was centered on the COSIS distal stent protection strategy. The primary outcome is proportion of patients with functional independence defined as mRS score of 0-2 at 90 days after enrollment.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 150 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Xuan Sun as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All research centers continuously screened eligible patients according to unified standards. The study did not interfere with the choice of treatment options. Whether the patients received intravascular therapy was determined by clinicians according to the condition, imaging characteristics, treatment risk and the joint decision of doctors and patients.
This is a prospective multicenter observational registry-based cohort study. Endovascular treatment is a routine clinical interventional procedure. The decision whether to perform endovascular treatment is made by treating clinicians, not assigned by study investigators. Investigators only collect real-world clinical data and follow-up outcomes of enrolled participants.
Exclusion Criteria:
Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.
Procedure: Endovascular Treatment Group
Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc.
Other: Standard medication
The recanalization strategy with COSIS distal stent protection technology as the core was used in endovascular treatment.In addition to thrombus removal, the device mainly uses its distal closed basket structure and stent guide wire to form protection and anchor fulcrum at the distal end of occlusion, so as to assist in balloon dilatation, thrombus removal or stent implantation of complex occlusive lesions, and reduce thrombus escape.
Standard drug therapy is implemented in accordance with the current guidelines for the diagnosis and treatment of cerebrovascular diseases and the routine of each center, mainly including antiplatelet or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc. The drug name, dose, route of administration, frequency of administration and course of treatment are determined by the clinician according to the patient's condition. The study only recorded the actual drug treatment and important adjustments.
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame: 90 days after enrollment
The overall distribution of mRS at 90 days after enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame: 90 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: 24 hours after treatment
National Institutes of Health Stroke Scale (NIHSS) score at discharge
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: At discharge
National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: 30 days after enrollment
National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Time frame: 90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment.
Time frame: 90 days after enrollment
Transient ischemic attack within 90 days after enrollment
Transient ischemic attack within 90 days after enrollment.
Time frame: 90 days after enrollment
All-cause mortality within 90 days after enrollment
All-cause mortality within 90 days after enrollment.
Time frame: 90 days after enrollment
Revascularization of target vessels within 90 days after enrollment
Revascularization of target vessels within 90 days after enrollment.
Time frame: 90 days after enrollment
The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b
The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis \<50% and final mTICI grade≥2b.
Time frame: At the end of the procedure
Degree of recanalization in the intravascular treatment cohort
Degree of recanalization in the intravascular treatment cohort.The mTICI scale evaluates angiographic recanalization after endovascular therapy for acute ischemic stroke. Grades range from 0 (no perfusion) to 3 (complete recanalization). mTICI grade≥2b is defined as successful recanalization.
Time frame: At the end of the procedure
Operation time of intravascular treatment cohort
Operation time of intravascular treatment cohort.
Time frame: During the procedure
Distribution of mRS scores at 6 months after enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame: 6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment.
Time frame: 6 months after enrollment
Transient ischemic attack at 6 months after enrollment
Transient ischemic attack at 6 months after enrollment.
Time frame: 6 months after enrollment
All-cause mortality at 6 months after enrollment
All-cause mortality at 6 months after enrollment.
Time frame: 6 months after enrollment
Revascularization of target vessels at 6 months after enrollment
Revascularization of target vessels at 6 months after enrollment.
Time frame: 6 months after enrollment
Distribution of mRS scores at 12 months after enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Time frame: 12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment.
Time frame: 12 months after enrollment
Transient ischemic attack at 12 months after enrollment
Transient ischemic attack at 12 months after enrollment.
Time frame: 12 months after enrollment
All-cause mortality at 12 months after enrollment
All-cause mortality at 12 months after enrollment.
Time frame: 12 months after enrollment
Revascularization of target vessels at 12 months after enrollment
Revascularization of target vessels at 12 months after enrollment.
Time frame: 12 months after enrollment
Adverse events within 12 months after enrollment
Adverse events events within 12 months after enrollment.
Time frame: 12 months after enrollment
Serious adverse events within 12 months after enrollment
Serious adverse events within 12 months after enrollment.
Time frame: 12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment.
Time frame: 12 months after enrollment
Ischemic stroke within 12 months after enrollment
Ischemic stroke within 12 months after enrollment.
Time frame: 12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment.
Time frame: 12 months after enrollment
All-cause death and other important clinical safety events within 12 months after enrollment
All-cause death and other important clinical safety events within 12 months after enrollment.
Time frame: 12 months after enrollment
Proportion of at least one complication in the intravascular therapy cohort
The intravascular treatment cohort included perioperative vascular dissection, vascular perforation or rupture, distal embolization, acute occlusion, re-occlusion, cerebral hyperperfusion syndrome and puncture site complications.
Time frame: Perioperative
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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