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Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)

25 juin 2026 mis à jour par: Advanced Bifurcation Systems Inc.

Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)

This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

This is a prospective, single-arm, single-center initial feasibility clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose.

All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.

Type d'étude

Interventionnel

Inscription (Réel)

13

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.

Lieux d'étude

  • Paraguay
      • Asunción, Paraguay
        • Cirugía Cardiovascular, Sanatorio Italiano

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:

Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart.

Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements.

Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year.

Exclusion Criteria:

Are currently participating in another investigational drug or device study that could interfere with this study.

Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy.

Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results.

Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition.

Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels.

Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function.

Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions.

Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed.

Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure.

Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel).

Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.

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: Faisabilité de l'appareil
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patients with coronary bifurcation lesions
Patients undergoing PCI to treat a bifurcation lesion
Dispositif: MD-SBA DES System
The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.
Autres noms:
  • Percutaneous coronary Intervention (PCI)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Procedure Success
Délai: Periprocedural
To determine whether the device can be successfully delivered and implanted, as measured by attainment of <30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).
Periprocedural

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
MACE
Délai: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization. Components of MACE, including cardiac death and myocardial infarction, may also be summarized.
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
TVF
Délai: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Target Lesion Revascularization of the Side Branch
Délai: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.
30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Stent thrombosis
Délai: 6-months, 1-year, 2-years, and 3-years post index procedure
Percentage of subjects with late stent thrombosis.
6-months, 1-year, 2-years, and 3-years post index procedure
Acute Success
Délai: Index procedure
Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis <30% and adequate side branch flow.
Index procedure
Side Branch Access
Délai: Index procedure
Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.
Index procedure
Bleeding / Vascular Complications
Délai: Hospital discharge
Percentage of subjects with bleeding or vascular complications.
Hospital discharge
Procedure Time
Délai: Index procedure
Duration of the index procedure in minutes
Index procedure
Fluoroscopy Time
Délai: Index procedure
Total fluoroscopy duration during index procedure in minutes
Index procedure
Contrast Volume
Délai: Index procedure
Total volume of contrast media used during index procedure in milliliters
Index procedure

Collaborateurs et enquêteurs

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

Parrainer

Advanced Bifurcation Systems Inc.

Les enquêteurs

  • Directeur d'études: Randy E David, PhD, Advanced Bifurcation Systems Inc.
  • Chaise d'étude: Mehran Khorsandi, MD, Advanced Bifurcation Systems Inc.
  • Chercheur principal: Adrian Ebner, MD, Sanatorio Italiano, Asunción, Paraguay

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 (Réel)

16 septembre 2025

Achèvement primaire (Réel)

19 novembre 2025

Achèvement de l'étude (Estimé)

19 novembre 2028

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juin 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

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 082825

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

Oui

produit fabriqué et exporté des États-Unis.

Oui

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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