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L'essai clinique NCT05755711 (EMPOWER CAD) 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. | ||
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Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)
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 NCT05755711 (EMPOWER CAD) est un essai observationnel pour Maladie de l'artère coronaire. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 3 mai 2023 et vise à recruter 399 participants. Dirigé par Shockwave Medical, Inc., l'essai devrait être terminé d'ici le 1 avril 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 1 mai 2025.
Résumé succinct
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
Description détaillée
Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.
Titre officiel
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Conditions
Maladie de l'artère coronaireAutres identifiants de l'essai
- EMPOWER CAD
- CP 67712
Numéro NCT
Date de début (réel)
2023-05-03
Dernière mise à jour publiée
2025-05-01
Date de fin (estimée)
2028-04
Inscription (estimée)
399
Type d'essai
Observationnel
Statut
Actif, pas en recrutement
Mots clés
Intravascular Lithotripsy
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Female subjects referred for percutaneous coronary intervention Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. | Shockwave Medical Coronary IVL System Coronary Intravascular Lithotripsy (IVL) |
Critère principal d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Primary Safety Endpoint | Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR). | 30 days |
Primary Effectiveness Endpoint | Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated). | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
- The subject is a non-pregnant female ≥18 years of age
- The subject meets indications for PCI and stent
- The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
- The subject is willing to comply with protocol-specified follow-up evaluations
- The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
- Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
- Subjects presenting with cardiogenic shock at the time of the index procedure
- Serious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow
- Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
- Subject is enrolled in any study of an investigational device or drug that may interfere with study results
Shockwave Medical, Inc.Aucune donnée de contact disponible
49 Centres de l'essai dans 5 pays
Antibes
Centre Hospitalier d'Antibes, Antibes, Antibes, 06606, France
BP 27617
Clinique Pasteur, Toulouse, BP 27617, 31076 Cedex 3, France
Paris
AP-HP Hopital Pitie-Salpetriere, Paris, Paris, 75013, France
Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier, Massy, 91300, France
California
Loma Linda University Health, Loma Linda, California, 92354, United States
Good Samaritan Hospital, Los Angeles, California, 90017, United States
Kaiser Permanente - San Francisco Medical Center, San Francisco, California, 94118, United States
Stanford University, Stanford, California, 94305, United States
Colorado
South Denver Cardiology Associates, P.C, Littleton, Colorado, 80120, United States
Connecticut
Yale New Haven Hospital, New Haven, Connecticut, 06510, United States
Florida
Morton Plant Hospital, Clearwater, Florida, 33756, United States
Tallahassee Research Institute, Tallahassee, Florida, 32308, United States
Georgia
Emory Hospital, Atlanta, Georgia, 30308, United States
Piedmont Heart Institute, Atlanta, Georgia, 30309, United States
Northside Hospital, Atlanta, Georgia, 30342, United States
Illinois
Northwestern University, Evanston, Illinois, 60208, United States
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Louisiana
Tulane University Center for Clinical Research, New Orleans, Louisiana, 70112, United States
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
New Hampshire
New England Heart and Vascular Institute, Manchester, New Hampshire, 03102, United States
New York
NYU Langone Health, Brooklyn, New York, 11220, United States
NYU Langone Health, New York, New York, 10016, United States
Columbia University Medical Center, New York, New York, 10032, United States
St. Francis Hospital, Roslyn, New York, 11576, United States
Montefiore Medical Center, The Bronx, New York, 10467, United States
Ohio
The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy, Cincinnati, Ohio, 45219, United States
Pennsylvania
WellSpan York Hospital, York, Pennsylvania, 17403, United States
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States
South Carolina
MUSC Health University Medical Center, Charleston, South Carolina, 29425, United States
Tennessee
Centennial Heart, Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Texas
DHR Health Heart Institute, McAllen, Texas, 78503, United States
Baylor Scott & White Research Institute, Plano, Texas, 75093, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
Virginia
Inova Fairfax Medical Campus, Falls Church, Virginia, 22042, United States
Washington
Overlake Medical Center, Bellevue, Washington, 98004, United States
University of Washington Medical Center, Seattle, Washington, 98195, United States
Langenbeckstr. 1
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz, Mainz, Langenbeckstr. 1, 55131, Germany
Nordallee 1
Krankenhaus der Barmherzigen Bruder Trier, Trier, Nordallee 1, 54292, Germany
Heart and Lung Center Leipzig, Leipzig, Germany
A Coruña
Hospital Clinico De Santiago, Santiago de Compostela, A Coruña, Spain
Hospital del Mar, Barcelona, Spain
Hospital Universitario Reina Sofia, Córdoba, Spain
Hospital Clínico San Carlos, Madrid, Spain
Golden Jubilee National Hospital, Clydebank, G81 4HX, United Kingdom
Liverpool Heart and Chest Hospital, Liverpool, L14 3PE, United Kingdom
St. George's Hospital, London, SW17 0QT, United Kingdom
Hammersmith Hospital, London, W12 0HS,, United Kingdom