Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents
11 mars 2019 mis à jour par: Yonsei University
Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study
This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion .
The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography.
After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry.
However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible.
Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress.
To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.
Type d'étude
Observationnel
Inscription (Anticipé)
894
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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Seoul, Corée, République de, 120-752
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
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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
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants who already enrolled in DETECT-OCT
La description
Inclusion Criteria:
- 1. patients who were enrolled in the previous DETECT-OCT study
- 2. Patients who agreed with informed consents
Exclusion Criteria:
- 1. Patients who disagreed with informed consents
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
Cohortes et interventions
Groupe / Cohorte |
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OCT-guided group
OCT-guided PCI with EES or BES
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Angiography-guidance group
Angio-guided PCI with EES or BES
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall survival
Délai: At 5 years
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Free from death
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At 5 years
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Overall survival
Délai: At 10 years
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Free from death
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At 10 years
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Cardiac death
Délai: At 5 years
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Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
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At 5 years
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Cardiac death
Délai: At 10 years
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Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
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At 10 years
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Myocardial infarction
Délai: At 5 years
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(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis.
The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI.
Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
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At 5 years
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Myocardial infarction
Délai: At 10 years
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(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis.
The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI.
Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
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At 10 years
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Target lesion revascularization
Délai: At 5 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion.
The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
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At 5 years
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Target lesion revascularization
Délai: At 10 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion.
The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
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At 10 years
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Target vessel revascularization
Délai: At 5 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
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At 5 years
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Target vessel revascularization
Délai: At 10 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
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At 10 years
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Stent thrombosis
Délai: At 5 years
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Based on the Academic Research Consortium (ARC) definition.
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At 5 years
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Stent thrombosis
Délai: At 10 years
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Based on the Academic Research Consortium (ARC) definition.
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At 10 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Anticipé)
1 avril 2019
Achèvement primaire (Anticipé)
1 octobre 2026
Achèvement de l'étude (Anticipé)
1 avril 2027
Dates d'inscription aux études
Première soumission
11 mars 2019
Première soumission répondant aux critères de contrôle qualité
11 mars 2019
Première publication (Réel)
13 mars 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4-2018-1167
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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