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

21 september 2026 bijgewerkt door: Xuan Sun

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Xuan Sun, MD
  • Telefoonnummer: 13810926284
  • E-mail: sxuan@yeah.net

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospitall, Capital Medical University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The overall distribution of mRS at 90 days after enrollment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 90 days after enrollment

Transient ischemic attack within 90 days after enrollment.
90 days after enrollment
All-cause mortality within 90 days after enrollment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At the end of the procedure

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
Tijdsspanne: At the end of the procedure

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
Tijdsspanne: During the procedure

Operation time of intravascular treatment cohort.
During the procedure
Distribution of mRS scores at 6 months after enrollment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months after enrollment

Transient ischemic attack at 6 months after enrollment.
6 months after enrollment
All-cause mortality at 6 months after enrollment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 months after enrollment

Transient ischemic attack at 12 months after enrollment.
12 months after enrollment
All-cause mortality at 12 months after enrollment
Tijdsspanne: 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
Tijdsspanne: 12 months after enrollment

Revascularization of target vessels at 12 months after enrollment.
12 months after enrollment

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events within 12 months after enrollment
Tijdsspanne: 12 months after enrollment

Adverse events events within 12 months after enrollment.
12 months after enrollment
Serious adverse events within 12 months after enrollment
Tijdsspanne: 12 months after enrollment

Serious adverse events within 12 months after enrollment.
12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment
Tijdsspanne: 12 months after enrollment

Symptomatic intracranial hemorrhage within 12 months after enrollment.
12 months after enrollment
Ischemic stroke within 12 months after enrollment
Tijdsspanne: 12 months after enrollment

Ischemic stroke within 12 months after enrollment.
12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Perioperative

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xuan Sun

Onderzoekers

  • Hoofdonderzoeker: Xuan Sun, MD, Beijing Tiantan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

9 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2026

Eerst geplaatst (Werkelijk)

28 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HX-A-2026022

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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