bêta
IA Trial Radar
L'essai clinique NCT05423379 (SPIRIT XLV PAS) pour Maladie de l'artère coronaire est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
Un essai clinique correspond aux filtres sélectionnés
Vue en carte

XIENCE Skypoint Large Vessel Post Approval Study (SPIRIT XLV PAS)

Actif, pas en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05423379 (SPIRIT XLV PAS) est un essai observationnel pour Maladie de l'artère coronaire. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 14 septembre 2022 et vise à recruter 102 participants. Dirigé par Abbott, l'essai devrait être terminé d'ici le 30 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 janvier 2025.
Résumé succinct
SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.
Titre officiel

XIENCE Skypoint Large Vessel Post Approval Study

Conditions
Maladie de l'artère coronaire
Autres identifiants de l'essai
  • SPIRIT XLV PAS
  • ABT -CIP 10445
Numéro NCT
Date de début (réel)
2022-09-14
Dernière mise à jour publiée
2025-01-08
Date de fin (estimée)
2027-08-30
Inscription (estimée)
102
Type d'essai
Observationnel
Statut
Actif, pas en recrutement
Mots clés
ABT -CIP 10445
Coronary artery disease
XIENCE
Large Vessel
Skypoint
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)
XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Number of participants with Target Lesion Failure (TLF) at 1 year
TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR).
At 1 Year
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

General Inclusion Criteria

  1. Subject must be at least 18 years of age.

  2. Subject or a legally authorized representative must provide written informed consent per site requirements.

  3. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following:

    1. Abnormal stress or imaging stress test
    2. Abnormal computed tomography-fractional flow reserve (CT-FFR)
    3. Stenosis by visual estimation ≥ 70%
    4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio [iFR], or relative flow reserve [RFR])
  4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

  1. Patients who have lesion(s) in a vessel with reference vessel diameter > 4.25 mm and ≤ 5.25 mm as the target lesion

  2. Patients who receive at least one Skypoint LV stent

    1. Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents
    2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.

General Exclusion Criteria

  1. Patients who have contraindications of the Skypoint LV per the IFU
  2. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months.

Angiographic Exclusion Criteria:

  1. Patients who require three vessel treatment.

  2. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23

    1. Unprotected LM disease with a SYNTAX score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population
    2. A heart team consensus approach per site's standard of care (SOC) to enhance patient protection and optimal clinical practice for the left main treatment is required.
Aucune donnée de contact disponible
18 Centres de l'essai dans 3 pays

Midi-Pyrenees

Clinique Pasteur Toulouse, Toulouse, Midi-Pyrenees, 31300, France

Rhone

Hopital Cardiovasculaire et Pneumologique Louis Pradel, Lyon, Rhone, France

Arkansas

Arkansas Heart Hospital, Little Rock, Arkansas, 72211, United States

Florida

Memorial Hospital Jacksonville, Jacksonville, Florida, 32216, United States
Tallahassee Research Institute, Tallahassee, Florida, 32308, United States

Kansas

Via Christi Regional Medical Center - St. Francis Campus, Wichita, Kansas, 67226, United States

Nebraska

Bryan Heart, Lincoln, Nebraska, 68506, United States

New York

Lenox Hill Hospital, New York, New York, 10075, United States

Pennsylvania

Pinnacle Health System, Wormleysburg, Pennsylvania, 17043, United States

South Carolina

Anmed Health, Anderson, South Carolina, 29621, United States
Greenville Health System, Greenville, South Carolina, 29605-5601, United States

Texas

Hendrick Medical Center, Abilene, Texas, 79601, United States
Austin Heart, Austin, Texas, 78756, United States
The Heart Hospital Baylor Plano, Plano, Texas, 75074, United States
Shannon Clinic, San Angelo, Texas, 76903, United States
Hospital Clinico San Carlos, Madrid, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Hospital Virgen de Rocio, Seville, Spain