RESOLUTE China Registry: (R-C Registry)
4 aprile 2018 aggiornato da: Medtronic Vascular
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1800
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Beijing, Cina, 100000
- Beijing Fumwai Hospital
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Beijing, Cina, 100044
- Peiking University People's Hospital
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Fuzhou, Cina, 350001
- Fujian Medical University Union Hospital
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Guangdong, Cina, 510000
- Guangdong Provincial People's Hospital
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Nanjing, Cina, 210006
- Nanjing First Hospital
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Wuhan, Cina, 430022
- Wuhan Asia Heart Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Target lesion failure (TLF)
Lasso di tempo: 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.
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12m
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall stent thrombosis
Lasso di tempo: 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
Lasso di tempo: At the end of the index procedure or during hospital stay
|
At the end of the index procedure or during hospital stay
|
|
|
TLF
Lasso di tempo: 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
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30 days, 6 months, 2 year, 3 year, 4 year and 5 year
|
|
All deaths (cardiac, vascular and non-cardiovascular)
Lasso di tempo: 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
Lasso di tempo: 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)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Myocardial infarction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
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Major adverse cardiac events (MACE)
Lasso di tempo: 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
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jiyan Chen, MD, Guangdong Provincial People's Hospital
- Investigatore principale: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
- Investigatore principale: Lianglong Chen, MD, Fujian Medical University Union Hospital
- Investigatore principale: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
- Investigatore principale: Weimin Wang, MD, Peiking University People's Hospital
- Investigatore principale: Guoying Zhu, MD, Wuhan Asia Heart Hospital
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 dicembre 2010
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
15 dicembre 2017
Date di iscrizione allo studio
Primo inviato
17 novembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
17 novembre 2010
Primo Inserito (Stima)
18 novembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 aprile 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 aprile 2018
Ultimo verificato
1 aprile 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IP124
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .