EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuan Sun
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years
The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
The time from LKW or the time of finding symptoms is 24 hours to 72 hours; or more than 72 hours but not more than 30 days, and there are neurological deterioration or fluctuation
Imaging findings suggest that there may still be salvageable brain tissue, which meets any of the following conditions: perfusion imaging examination shows that the ischemic core volume < 70 ml and the mismatch ratio > 1.2; CTA or DSA showed moderate or good collateral circulation; MRI-DWI showed a significant mismatch between lesion size and clinical symptoms
Disqualifiers
Large area cerebral infarction or imaging showed obvious space occupying effect, such as ASPECTS<6 points,or brainstem infarction area exceeded 1/3 of the corresponding anatomical area
Isolated extracranial carotid or vertebral artery occlusion
Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
Intracranial hemorrhage occurred in the past 3 months
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular Treatment Group
Procedure/SurgeryThe 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 medication
Other interventionStandard 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Endovascular Treatment Cohort1 intervention
Group B: Standard Medical Therapy Cohort1 intervention
Trial outcomes
Primary outcomes
1
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 enrollmentSecondary outcomes
1
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 enrollment2
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 treatment3
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 discharge4
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 enrollmentOther outcomes
1
Adverse events within 12 months after enrollment
Adverse events events within 12 months after enrollment.
Time frame
12 months after enrollment2
Serious adverse events within 12 months after enrollment
Serious adverse events within 12 months after enrollment.
Time frame
12 months after enrollment3
Symptomatic intracranial hemorrhage within 12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment.
Time frame
12 months after enrollment4
Ischemic stroke within 12 months after enrollment
Ischemic stroke within 12 months after enrollment.
Time frame
12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xuan Sun
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Source ClinicalTrials.gov
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