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- Essai clinique NCT02013349
DESolve Post-Approval Study
6 avril 2020 mis à jour par: Elixir Medical Corporation
POST-MARKET EVALUATION OF DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
DESolve is not currently approved for sale in the United States.
Type d'étude
Interventionnel
Inscription (Réel)
102
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
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Bad Segeberg, Allemagne, 23795
- Herz-Kreislaufzentrum Bad Segeberg
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Giessen, Allemagne, 35392
- Universitätsklinikum Gießen und Marburg GmbH
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Münster, Allemagne, 48149
- Universitätsklinikum Münster
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Trier, Allemagne, 54292
- Krankenhaus der Barmherzigen Brüder
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Milan, Italie, 20132
- Ospendale San Raffaele
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Amman, Jordan, 11152
- Jordan Hospital
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Irbid, Jordan, 22110
- King Abdullah University Hospital
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patient must be at least 18 years of age
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve NE BCSS and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient must agree to undergo all clinical study required follow-up visits
- Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
Angiographic Inclusion Criteria - Target Lesion/Vessel Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by visual estimation or QCA
- Target lesion must measure ≤ 24 mm in length
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1
- Percutaneous intervention of lesions in the target vessel if:
- Not part of a clinical investigation
- ≥ 6 months prior to the study index procedure
- ≥ 9 months after the study index procedure (planned)
- Previous intervention was distal to and > 10 mm from the target lesion
Exclusion Criteria:
- Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
- Patient is currently experiencing clinical symptoms consistent with AMI
- Patient requires the use of any rotablator intervention during the index procedure
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) < 30%
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus)
- Patient is receiving chronic anticoagulation therapy (e.g., heparin, Coumadin) that cannot be stopped and restarted according to local hospital standard procedures
- Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
- Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease
- Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
- Patient has had a significant GI or urinary bleed within the past six months
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- Patient is already participating in another clinical study
- Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
- Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority
Angiographic Exclusion Criteria - Target Lesion/Vessel
- Target lesion(s) meets any of the following criteria:
- Aorto-ostial location
- Left main location
- Located within 5 mm of the origin of the LAD or LCX
- Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- Lesion involving a side branch >2mm in diameter or bifurcation
- Previous placement of a scaffold proximal to or within 10 mm of the target lesion
- Total occlusion (TIMI flow 0), or sub-total occlusion (TIMI flow 1)
- Excessive tortuosity proximal to or within the lesion
- Angulation (≥ 45o) proximal to or within the lesion
- Calcification moderate or heavy
- Previous intervention restenosis
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: DESyne Novolimus Eluting CSS
approved device continued access
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Major Adverse Cardiac Events (MACE)
Délai: 1 month
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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1 month
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Major Adverse Cardiac Events (MACE)
Délai: 6 months
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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6 months
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Major Adverse Cardiac Events (MACE)
Délai: 12 months
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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12 months
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Major Adverse Cardiac Events (MACE)
Délai: 2 years
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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2 years
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Major Adverse Cardiac Events (MACE)
Délai: 3 years
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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3 years
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Major Adverse Cardiac Events (MACE)
Délai: 4 years
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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4 years
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Major Adverse Cardiac Events (MACE)
Délai: 5 years
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Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
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5 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
22 avril 2014
Achèvement primaire (Réel)
1 octobre 2015
Achèvement de l'étude (Réel)
1 avril 2019
Dates d'inscription aux études
Première soumission
6 décembre 2013
Première soumission répondant aux critères de contrôle qualité
16 décembre 2013
Première publication (Estimation)
17 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 avril 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 avril 2020
Dernière vérification
1 avril 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ELX-CL-1203
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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