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A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter

25 juin 2026 mis à jour par: GuoQiang Xu, Hebei General Hospital

Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial

This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis. They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone. The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain. This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone. The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).

Type d'étude

Interventionnel

Inscription (Estimé)

132

Phase

  • N'est pas applicable

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

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Aged between 18 and 80 years (inclusive), with no gender restriction.
  2. Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
  3. Suitable for carotid artery stenting.
  4. Good compliance, voluntarily signed the informed consent form, and able to follow up as required.

Exclusion Criteria:

  1. Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
  2. Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
  3. Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
  4. Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
  5. Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
  6. Presence of substantial acute or subacute thrombus adjacent to the lesion.
  7. mRS > 3.
  8. Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.
  9. Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.
  10. Patients with prior stent treatment in the ipsilateral head and neck vessels.
  11. Patients with end-stage renal failure requiring dialysis.
  12. Life expectancy less than 6 months.
  13. Patients unsuitable for magnetic resonance imaging (MRI) for any reason.
  14. Patients with absolute or relative contraindications to antiplatelet therapy.
  15. Inability to cooperate with the study due to dementia or mental disorder.

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

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Combined Cerebral Protection (BGC + Filter + intermediate catheter)
Participants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter.
Dispositif: Balloon Guide Catheter
Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
Comparateur actif: Standard Protection Group (Filter Alone)
Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection.
Dispositif: Filter
Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
Délai: within 48 hours (±24 hours) post-procedure
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours). New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
within 48 hours (±24 hours) post-procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Device Success Rate
Délai: during the procedure
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
during the procedure
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
Délai: within 30-day post-procedure
The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
within 30-day post-procedure
Changes in mRS score at 30 days and 90 days post-procedure.
Délai: 30 days and 90 days post-procedure
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death).
30 days and 90 days post-procedure
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
Délai: 30 days and 90 days post-procedure
Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting <24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
30 days and 90 days post-procedure
Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
Délai: 30 days and 90 days post-procedure
Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting <24 hours with no acute infarct on neuroimaging.
30 days and 90 days post-procedure
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
Délai: during the procedure
Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).
during the procedure
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
Délai: 30 days and 90 days post-procedure
The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
30 days and 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Délai: within 48 hours (±24 hours) post-procedure
Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.
within 48 hours (±24 hours) post-procedure
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
Délai: within 48 hours (±24 hours) post-procedure
Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.
within 48 hours (±24 hours) post-procedure
Incidence of all-cause mortality within 90 days post-procedure.
Délai: 90 days post-procedure
Incidence of death from any cause occurring within 90 days following the procedure.
90 days post-procedure
Incidence of device defects.
Délai: during the procedure
The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
during the procedure

Collaborateurs et enquêteurs

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

Parrainer

Hebei General Hospital

Les enquêteurs

  • Chercheur principal: Guodong Xu, Hebei General 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 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

25 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BGC-2026-01

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

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