Osservatorio per valutare i sistemi di stent polimerici bioriassorbibili a rilascio di Sirolimus Yukon Choice PC e Yukon Chrome PC Sirolimus (YuChooSeR)
Osservatorio multicentrico per valutare i sistemi Yukon Choice PC e Yukon Chrome PC Sirolimus a eluizione di stent polimerici bioriassorbibili nella pratica clinica di routine
The TRANSLUMINA GmbH YuChooSeR Observatory is a prospective, multicentric post-marketing observatory designed to evaluate large scale safety and reliability of the Yukon Choice PC and the Yukon Chrome PC stents systems use in routine, clinical practice.
This based observatory will enroll 3000 patients to 30 sites in France.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
TRANSLUMINA GmbH has launched clinical programs to demonstrate the safety and efficacy of its technology.
The Translumina Yukon Choice PC drug-eluting stent, coated with Rapamycin (Sirolimus) and the biodegradable component polylactide (PLA), has an excellent history of pre-clinical and clinical results.
The Yukon Chrome PC has the identical coating technique and coating properties (dosage, thickness) like the clinically proven Yukon Choice PC.
In two independent trials ISAR-TEST 3 and ISAR-TEST 4 the Yukon DES platform showed angiographic and clinical equivalence with the Cypher stent after 1 year and 3 years of follow-up.
Latest clinical data, published by G.Stefanini et al, show the excellent long-term outcome of the Yukon biodegradable polymer DES technology in a meta-analysis, comparing the clinical outcome after 4 years in more than 4000 patients with the Cypher stent. This analysis shows for the first time that the definite Very Late Stent Thrombosis (VLST) can be reduced statistically significant by using the biodegradable PLA polymer coating technology of the Yukon DES.
An additional sub-group analysis shows also benefit in difficult patient groups like diabetics and patients with acute myocardial infarkt.
Due to this excellent clinical outcome the Yukon DES technology is recommended by the latest ESC guidelines for myocardial revascularization.
The final 5 years long-term clinical follow-up of the ISAR-TEST 4 randomized controlled clinical trial showed excellent safety and efficacy data for the Yukon DES when compared with the Cypher and Xience V stent. The definite and probable stent thrombosis was only 1,2% for the Yukon compared to 1,4% and 2,4% for the 2 permanent polymer coated competitor DES.
In a continued approach to collect safety and efficiency data on its products, TRANSLUMINA GmbH is determined to collect safety and efficiency information at a very large scale. Based on all this, the Yukon Choice PC & the Yukon Chrome PC stents have been designed to treat coronary arteries in a relatively easy and simple-to-achieve manner, while providing a higher level of clinical efficacy.
Additionally, the Observatory is aimed to provide a learning tool that will help to define best practices/techniques as all results will be fed back to participants and to a larger audience through publications.
In this Observatory, analyses will be performed per clinical presentation and per stent type.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Aix-en-Provence, Francia
- Clinique Axium
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Colmar, Francia
- Hopital A. Schweitzer - Ghca
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Compiègne, Francia
- Centre Hospitalier de Compiègnes
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Corbeil-Essonnes, Francia
- Centre Hospitalier Sud Francilien
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Essey-lès-Nancy, Francia
- Clinique Louis Pasteur
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Grenoble, Francia
- GHM Grenoble
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Haguenau, Francia
- Centre Hospitalier Haguenau
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Marseille, Francia
- Hopital privé Beauregard
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Montauban, Francia
- Clinique Pont de Chaume
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Nantes, Francia
- Hopital Privé du Confluent
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Périgueux, Francia
- Centre Hospitalier de Périgueux
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Quimper, Francia
- Centre Hospitalier de Quimper
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Rennes, Francia
- Polyclinique Saint-Laurent
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Rennes, Francia
- Clinique Saint Hilaire
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Soissons, Francia
- Centre Hospitalier de Soissons
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St-Malo, Francia
- Centre Hospitalier de Saint Malo
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Tarbes, Francia
- Centre Hospitalier de Bigorre
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Toulouse, Francia
- Clinique Pasteur
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Vannes, Francia
- Centre Hospitalier de Vannes
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients with symptomatic ischemic heart disease requiring stenting. All patients selected by the investigator to receive a Yukon Choice PC and/or a Yukon Chrome PC stent can be enrolled. Patient must be over 18 years old and be informed verbally and in writing about the nature and aim of the study.
Descrizione
Inclusion Criteria:
- Any patient suitable for implantation with a Yukon Choice PC or a Yukon Chrome PC stent according to current guidelines can be enrolled in this observatory
- Patient must be over 18 years old.
Exclusion Criteria:
- Patient not able to understand the information given for collection, transfer and processing of personal data before participation, may not be enrolled in this observatory.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up
Lasso di tempo: 12 months follow-up
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Target Lesion Failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial Infarction and clinically indicated target lesion revascularization (TLR) by percutaneous or surgical methods. |
12 months follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Device Success
Lasso di tempo: 12 months follow-up
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Device Success defined as successful delivery and deployment of the assigned device at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of <30% (by visual estimation) |
12 months follow-up
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Procedure Success
Lasso di tempo: 12 months follow-up
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Procedure Success defined as Device Success without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of first seven days post index procedure. |
12 months follow-up
|
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Reperfusion
Lasso di tempo: 12 months follow-up
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Reperfusion measured by TIMI flow at the end of the procedure. |
12 months follow-up
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Didié Tchétché, Dr, Clinique Pasteur
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2018-A03455-50
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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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 .