EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days

EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days: A Prospective, Multicenter, Real-world Cohort 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Intracranial Large Vessel Occlusion
• Intervention / Treatment: Procedure: Endovascular Treatment Group; Other: Standard medication

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Xuan Sun, MD; Phone Number: 13810926284; Email: sxuan@yeah.net

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospitall, Capital Medical University
      • Contact: Xuan Sun, MD; Phone Number: +8613810926284; Email: sxuan@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

1. Age≥18 years
2. The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
3. 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
4. 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
5. The modified Rankin Scale score (mRS) before onset was 0-1
6. The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent

Exclusion Criteria:

1. 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
2. Isolated extracranial carotid or vertebral artery occlusion
3. Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
4. Intracranial hemorrhage occurred in the past 3 months
5. There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
6. Severe liver and kidney function damage, which may affect treatment or follow-up
7. Pregnant or lactating women
8. The estimated survival time is less than 1 year
9. Unable to complete 90-day clinical follow-up or main outcome assessment
10. Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
11. Other circumstances that the researcher believes are not suitable for participating in this study

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular Treatment Cohort; 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; 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 Medical Therapy Cohort; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment	The recurrence rate of stroke within 90 days after enrollment.	90 days after enrollment
Transient ischemic attack within 90 days after enrollment	Transient ischemic attack within 90 days after enrollment.	90 days after enrollment
All-cause mortality within 90 days after enrollment	All-cause mortality within 90 days after enrollment.	90 days after enrollment
Revascularization of target vessels within 90 days after enrollment	Revascularization of target vessels within 90 days after enrollment.	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.	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.	At the end of the procedure
Operation time of intravascular treatment cohort	Operation time of intravascular treatment cohort.	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.	6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment	The recurrence rate of stroke at 6 months after enrollment.	6 months after enrollment
Transient ischemic attack at 6 months after enrollment	Transient ischemic attack at 6 months after enrollment.	6 months after enrollment
All-cause mortality at 6 months after enrollment	All-cause mortality at 6 months after enrollment.	6 months after enrollment
Revascularization of target vessels at 6 months after enrollment	Revascularization of target vessels at 6 months after enrollment.	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.	12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment	The recurrence rate of stroke at 12 months after enrollment.	12 months after enrollment
Transient ischemic attack at 12 months after enrollment	Transient ischemic attack at 12 months after enrollment.	12 months after enrollment
All-cause mortality at 12 months after enrollment	All-cause mortality at 12 months after enrollment.	12 months after enrollment
Revascularization of target vessels at 12 months after enrollment	Revascularization of target vessels at 12 months after enrollment.	12 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events within 12 months after enrollment	Adverse events events within 12 months after enrollment.	12 months after enrollment
Serious adverse events within 12 months after enrollment	Serious adverse events within 12 months after enrollment.	12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment	Symptomatic intracranial hemorrhage within 12 months after enrollment.	12 months after enrollment
Ischemic stroke within 12 months after enrollment	Ischemic stroke within 12 months after enrollment.	12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment	Hemorrhagic stroke within 12 months after enrollment.	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.	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.	Perioperative

Collaborators and Investigators

• Sponsor: Xuan Sun
• Investigators: Principal Investigator: Xuan Sun, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 9, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 28, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Endovascular Therapy; COSIS Distal Stent Protection Technique; Standard Medication; Ultra Late Window
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: HX-A-2026022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No