Intracranial Large Vessel OcclusionNCT07843836
EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days
An observational study of Intracranial Large Vessel Occlusion and Ischemic Stroke, run by Xuan Sun at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Large Vessel Occlusion, Ischemic Stroke
- What is being tested?
- Endovascular Treatment Group and Standard medication
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospitall, Capital Medical University
Beijing, Beijing Municipality, 100070
Xuan Sun, MD, +8613810926284, sxuan@yeah.net
About this study
Official title: 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.
Read the 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.
- Being tested
- Endovascular Treatment Group, Standard medication
- Keywords
- COSIS Distal Stent Protection Technique, Endovascular Therapy, Standard Medication, Ultra Late Window
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Treatment GroupProcedure or surgery
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 medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment Cohort | Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy. Receives: 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. Receives: Other: Standard medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after enrollment
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment
The recurrence rate of stroke within 90 days after enrollment.
Measured: 90 days after enrollment
Transient ischemic attack within 90 days after enrollment
Transient ischemic attack within 90 days after enrollment.
Measured: 90 days after enrollment
All-cause mortality within 90 days after enrollment
All-cause mortality within 90 days after enrollment.
Measured: 90 days after enrollment
Revascularization of target vessels within 90 days after enrollment
Revascularization of target vessels within 90 days after enrollment.
Measured: 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.
Measured: 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.
Measured: At the end of the procedure
Operation time of intravascular treatment cohort
Operation time of intravascular treatment cohort.
Measured: 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.
Measured: 6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment
The recurrence rate of stroke at 6 months after enrollment.
Measured: 6 months after enrollment
Transient ischemic attack at 6 months after enrollment
Transient ischemic attack at 6 months after enrollment.
Measured: 6 months after enrollment
All-cause mortality at 6 months after enrollment
All-cause mortality at 6 months after enrollment.
Measured: 6 months after enrollment
Revascularization of target vessels at 6 months after enrollment
Revascularization of target vessels at 6 months after enrollment.
Measured: 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.
Measured: 12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment
The recurrence rate of stroke at 12 months after enrollment.
Measured: 12 months after enrollment
Transient ischemic attack at 12 months after enrollment
Transient ischemic attack at 12 months after enrollment.
Measured: 12 months after enrollment
All-cause mortality at 12 months after enrollment
All-cause mortality at 12 months after enrollment.
Measured: 12 months after enrollment
Revascularization of target vessels at 12 months after enrollment
Revascularization of target vessels at 12 months after enrollment.
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuan Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuan Sun, Beijing Tiantan Hospital
- Investigators
- Xuan Sun, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843836
- Sponsor's protocol ID
- HX-A-2026022
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No