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Endovascular Treatment of Chronic Intracranial Artery Occlusion

10. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

382

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: control group
Standard pharmacological treatment
Arzneimittel: 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.
Experimental: Test group
Endovascular treatment combined with standard pharmacological treatment
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stroke or death within 30 days after enrollment, or any ischemic stroke of the qualifying artery after 30 days through 12 months after enrollment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disabling stroke within 12 months post-procedure
Zeitfenster: 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
Zeitfenster: End of the procedure
End of the procedure
Any stroke within 12 months post-procedure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months post-procedure
12 months post-procedure
Any stroke or death within 30 days post-randomization
Zeitfenster: Within 30 days post-randomization
Within 30 days post-randomization
Procedure-related complications
Zeitfenster: Perioperative period / Within 30 days post-procedure
Perioperative period / Within 30 days post-procedure

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2029

Studienabschluss (Geschätzt)

1. August 2030

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ETP-C

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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