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

21 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

150

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Xuan Sun, MD
  • Numéro de téléphone: 13810926284
  • E-mail: sxuan@yeah.net

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100070
        • Beijing Tiantan Hospitall, Capital Medical University
        • Contact:
          • Xuan Sun, MD
          • Numéro de téléphone: +8613810926284
          • E-mail: sxuan@yeah.net

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Endovascular Treatment Cohort

Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy.
Procédure: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The overall distribution of mRS at 90 days after enrollment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 90 days after enrollment

Transient ischemic attack within 90 days after enrollment.
90 days after enrollment
All-cause mortality within 90 days after enrollment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: During the procedure

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

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

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

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Adverse events within 12 months after enrollment
Délai: 12 months after enrollment

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

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

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

Ischemic stroke within 12 months after enrollment.
12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Xuan Sun

Les enquêteurs

  • Chercheur principal: Xuan Sun, MD, Beijing Tiantan Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

9 septembre 2026

Première soumission répondant aux critères de contrôle qualité

21 septembre 2026

Première publication (Réel)

28 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HX-A-2026022

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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