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

NCT07843836 | Not Yet Recruiting

• 1 other identifier: HX-A-2026022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Large Vessel Occlusion; Ischemic Stroke

Keywords

COSIS Distal Stent Protection Technique; Endovascular Therapy; Standard Medication; Ultra Late Window

Outcome Measures

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.

  90 days after enrollment

Secondary Outcomes (22)

• The overall distribution of mRS at 90 days after enrollment

  90 days after enrollment

• National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment

  24 hours after treatment

• National Institutes of Health Stroke Scale (NIHSS) score at discharge

  At discharge

• National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment

  30 days after enrollment

• National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment

  90 days after enrollment

Other Outcomes (7)

• Adverse events within 12 months after enrollment

  12 months after enrollment

• Serious adverse events within 12 months after enrollment

  12 months after enrollment

• Symptomatic intracranial hemorrhage within 12 months after enrollment

  12 months after enrollment

Study Arms (2)

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

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

Interventions

Standard medication OTHER

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.

Standard Medical Therapy Cohort

Endovascular Treatment Group PROCEDURE

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.

Endovascular Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• The modified Rankin Scale score (mRS) before onset was 0-1
• The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent

You may not qualify if:

• 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
• There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
• Severe liver and kidney function damage, which may affect treatment or follow-up
• Pregnant or lactating women
• The estimated survival time is less than 1 year
• Unable to complete 90-day clinical follow-up or main outcome assessment
• Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
• Other circumstances that the researcher believes are not suitable for participating in this study

Sponsors & Collaborators

• Xuan Sun: lead

Study Sites (1)

Beijing Tiantan Hospitall, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xuan Sun, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Sun, MD

CONTACT

13810926284; sxuan@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)