Essais cliniques sur Maladies cardiovasculaires, Maladie de l'artère coronaire, Artériosclérose, La cardiopathie ischémique, Lésion coronarienne sténosée - Registre des essais cliniques

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

Type d'étude

Observationnel

Inscription (Réel)

1800

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

Chine
- - Beijing, Chine, 100000
    - Beijing Fumwai Hospital
  - Beijing, Chine, 100044
    - Peiking University People's Hospital
  - Fuzhou, Chine, 350001
    - Fujian Medical University Union Hospital
  - Guangdong, Chine, 510000
    - Guangdong Provincial People's Hospital
  - Nanjing, Chine, 210006
    - Nanjing First Hospital
  - Wuhan, Chine, 430022
    - Wuhan Asia Heart Hospital

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

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

La description

Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

Age ≥ 18 years or minimum age as required by local regulations
The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
Intention to electively implant at least one Resolute stent
The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
Women with known pregnancy or who are lactating
High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Previous enrollment in the Resolute China Registry

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

Modèles d'observation: Cas uniquement
Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Target lesion failure (TLF) Délai: 12m	Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.	12m

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Overall stent thrombosis Délai: 12m	Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.	12m
Device success, Lesion success, Procedural success Délai: At the end of the index procedure or during hospital stay		At the end of the index procedure or during hospital stay
TLF Délai: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year	Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year	30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular) Délai: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year		30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	Q wave and non-Q wave MI	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Revascularization Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	target lesion and target vessel revascularization (TLR and TVR)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	hemorrhagic in nature	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF) Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE) Délai: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Collaborateurs et enquêteurs

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

Parrainer

Medtronic Vascular

Les enquêteurs

Chercheur principal: Jiyan Chen, MD, Guangdong Provincial People's Hospital
Chercheur principal: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
Chercheur principal: Lianglong Chen, MD, Fujian Medical University Union Hospital
Chercheur principal: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
Chercheur principal: Weimin Wang, MD, Peiking University People's Hospital
Chercheur principal: Guoying Zhu, MD, Wuhan Asia Heart Hospital

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.

Publications générales

Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23.

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)

1 décembre 2010

Achèvement primaire (Réel)

1 avril 2013

Achèvement de l'étude (Réel)

15 décembre 2017

Dates d'inscription aux études

Première soumission

17 novembre 2010

Première soumission répondant aux critères de contrôle qualité