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Endovascular Treatment of Chronic Intracranial Artery Occlusion

10 luglio 2026 aggiornato da: Hu Bo, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Endovascular Treatment of Chronic Intracranial Artery Occlusion: A Multicenter Randomized Controlled Trial

Comparison of the efficacy and safety of endovascular treatment versus medical treatment in patients with chronic intracranial artery occlusion.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a multicenter, outcome-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular therapy combined with standard medical therapy versus standard medical therapy alone in patients with chronic intracranial artery occlusion. A total of 382 patients (191 per group) aged ≥18 years with chronic occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery confirmed by CTA, MRA, or DSA will be enrolled and randomly assigned to the experimental group (endovascular therapy + standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is stroke or death within 30 days after enrollment, or any ischemic stroke related to the responsible artery occurring from 30 days to 12 months after enrollment. Secondary endpoints include any stroke or death within 30 days after randomization; any stroke within 12 months after the procedure; disabling stroke within 12 months after the procedure; fatal stroke within 12 months after the procedure; any death within 12 months after the procedure; mRS score at 12 months; NIHSS score at 12 months; successful reperfusion rate of endovascular therapy; and procedure-related complications.

Tipo di studio

Interventistico

Iscrizione (Stimato)

382

Fase

  • Non applicabile

Contatti e Sedi

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

Contatto studio

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age ≥18 years
  2. Occlusion of the unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery, as confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)
  3. Modified Rankin Scale (mRS) score of 0-2
  4. Presence of symptoms related to the occluded vessel, as determined by the physician, with the most recent symptom onset occurring more than 4 weeks and within 6 months prior to enrolment
  5. The subject or their legally authorised representative has provided written informed consent for the study

Exclusion Criteria:

  1. Evidence of hemorrhage on CT or MRI
  2. Large hemispheric infarction involving >50% of the middle cerebral artery territory on CT or MRI
  3. Severe pre-stroke disability (modified Rankin Scale score ≥2) or life expectancy <12 months
  4. Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.)
  5. Uncontrolled seizure at the time of stroke onset
  6. Baseline platelet count <50,000/μL
  7. Severe, persistent hypertension that remains uncontrolled despite active management (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg)
  8. Known inherited or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an international normalized ratio (INR) >3
  9. Suspected septic emboli or suspected bacterial endocarditis
  10. Known allergy to iodine, heparin, or anaesthetics, or other definite contraindications to endovascular procedures
  11. Pregnant women
  12. Other severe, progressive, or terminal diseases (as judged by the investigator), or life expectancy <24 months
  13. Prior attempted endovascular recanalization therapy before randomization
  14. Current participation in other studies involving investigational drugs or devices
  15. Evidence of intracranial tumour on CT or MRI (except meningioma)
  16. Excessive tortuosity of cervical vessels on CTA/MRA that may preclude endovascular therapy

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: control group
Standard pharmacological treatment
Droga: Standard pharmacological treatment
Standard pharmacological treatment: dual antiplatelet (aspirin 100 mg + clopidogrel 75 mg daily) for first 90 days, then single antiplatelet; high-intensity statin (atorvastatin 40-80 mg or rosuvastatin 20-40 mg daily) targeting LDL-C <1.8 mmol/L; strict BP control (<140/90 mmHg, or <130/80 mmHg in diabetics) and glycemic control (HbA1c <7.0%); uniformly applied across centers with pill-count adherence monitoring.
Sperimentale: Test group
Endovascular treatment combined with standard pharmacological treatment
Procedura: Endovascular treatment
Endovascular recanalization therapy for chronic atherosclerotic intracranial artery occlusion, including balloon angioplasty and/or stent implantation (e.g., self-expanding or drug-eluting stents) targeting the occluded unilateral middle cerebral artery, basilar artery, intracranial internal carotid artery, or vertebral artery. The procedure is performed under local or general anesthesia via femoral or radial arterial access, with peri-procedural dual antiplatelet therapy (e.g., aspirin plus clopidogrel) management according to standard institutional protocols.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment
Lasso di tempo: Within 30 days post-enrollment; and 30 days to 12 months post-enrollment
A stroke is defined as rapid loss of neurological function due to ischaemia or a haemorrhage. CT or MRI scanning is necessary to identify the stroke.
Within 30 days post-enrollment; and 30 days to 12 months post-enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disabling stroke within 12 months post-procedure
Lasso di tempo: 12 months post-procedure
Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. CT or MR scans will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.
12 months post-procedure
Successful reperfusion rate
Lasso di tempo: End of the procedure
End of the procedure
Any stroke within 12 months post-procedure
Lasso di tempo: 12 months post-procedure
Stroke is diagnosed by an independent outcome committee which is composed with experienced neurologists. Additional key neuro-images (CT or MR scans) will be collected as adjunct evidence for outcome classification of ischemic or hemorrhagic stroke.
12 months post-procedure
Residual stenosis of target vessel at 12 months
Lasso di tempo: 12 months post-procedure
The degree of target artery stenosis based on following-up neurovascular imaging
12 months post-procedure
Fatal stroke within 12 months post-procedure
Lasso di tempo: 12 months post-procedure
A cerebrovascular event that directly causes death or leads to irreversible brain damage resulting in imminent death based on CT or MR scans
12 months post-procedure
NIHSS score at 12 months
Lasso di tempo: 12 months post-procedure
The National Institutes of Health Stroke Scale (NIHSS) Scores range from a minimum of 0 (normal) to a maximum of 42 (profound impairment). Higher scores indicate a worse outcome, as they correspond to more severe stroke symptoms and poorer long-term prognosis.
12 months post-procedure
mRS score at 12 months
Lasso di tempo: 12 months post-procedure
Modified Rankin Scale：1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6
12 months post-procedure
Any death within 12 months post-procedure
Lasso di tempo: 12 months post-procedure
12 months post-procedure
Any stroke or death within 30 days post-randomization
Lasso di tempo: Within 30 days post-randomization
Within 30 days post-randomization
Procedure-related complications
Lasso di tempo: Perioperative period / Within 30 days post-procedure
Perioperative period / Within 30 days post-procedure

Collaboratori e investigatori

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

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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 agosto 2026

Completamento primario (Stimato)

1 agosto 2029

Completamento dello studio (Stimato)

1 agosto 2030

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ETP-C

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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