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

21 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

150

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xuan Sun, MD
  • Numero di telefono: 13810926284
  • Email: sxuan@yeah.net

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100070
        • Beijing Tiantan Hospitall, Capital Medical University
        • Contatto:
          • Xuan Sun, MD
          • Numero di telefono: +8613810926284
          • Email: sxuan@yeah.net

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Endovascular Treatment Cohort

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The overall distribution of mRS at 90 days after enrollment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 90 days after enrollment

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

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

Transient ischemic attack at 6 months after enrollment.
6 months after enrollment
All-cause mortality at 6 months after enrollment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months after enrollment

Transient ischemic attack at 12 months after enrollment.
12 months after enrollment
All-cause mortality at 12 months after enrollment
Lasso di tempo: 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
Lasso di tempo: 12 months after enrollment

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse events within 12 months after enrollment
Lasso di tempo: 12 months after enrollment

Adverse events events within 12 months after enrollment.
12 months after enrollment
Serious adverse events within 12 months after enrollment
Lasso di tempo: 12 months after enrollment

Serious adverse events within 12 months after enrollment.
12 months after enrollment
Symptomatic intracranial hemorrhage within 12 months after enrollment
Lasso di tempo: 12 months after enrollment

Symptomatic intracranial hemorrhage within 12 months after enrollment.
12 months after enrollment
Ischemic stroke within 12 months after enrollment
Lasso di tempo: 12 months after enrollment

Ischemic stroke within 12 months after enrollment.
12 months after enrollment
Hemorrhagic stroke within 12 months after enrollment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xuan Sun

Investigatori

  • Investigatore principale: Xuan Sun, MD, Beijing Tiantan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

9 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 settembre 2026

Primo Inserito (Effettivo)

28 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HX-A-2026022

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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