Cynergy: the CYPHER-NEVO Registry (CYNERGY)
Cynergy - The CYPHER-NEVO Registry. An Observational Registry, to Evaluate the Safety and Performance of the NEVO™ Sirolimus-eluting Coronary Stent in Routine Clinical Practice, and to Compare Its Safety and Performance With the CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES)
The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus and/or multi vessel disease.
The data will be collected from subjects treated with commercially available product and following routine clinical practice. Uniform, complete and accurate data will be collected on the subject's medical history, peri-procedurally, during the index hospitalization, and during follow-up.
Přehled studie
Postavení
Podmínky
Detailní popis
The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable intracoronary 316L stainless steel stent with a coating that consists of a blend of Sirolimus and polymers.
Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. Sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis.
The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. This design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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São Paulo, Brazílie
- Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
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Seoul, Korejská republika
- Asan Medical Center
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Meyrin, Švýcarsko
- Clinique La Tour
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion criteria:
- Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent once commercially available, or a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
Exclusion criteria:
- In case, during the index procedure, the subject was treated with a stent other than the CYPHER Select® Plus Sirolimus-eluting Coronary Stent or the NEVO™ Sirolimus-eluting Coronary Stent or a mix of the CYPHER Select® Plus SES and NEVO™ SES
- In case, during the index procedure, the subject was treated with other therapy (e.g. balloon angioplasty, cutting balloons, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.) in segments not ultimately treated with a CYPHER Select® Plus SES or NEVO™ SES.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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NEVO™ Sirolimus-eluting Coronary Stent System.
Subjects treated during routine clinical practice with the NEVO™ Sirolimus-eluting Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.
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CYPHER Select® Plus Coronary Stent
Subjects treated during routine clinical practice with the CYPHER Select® Plus Coronary Stent System and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Non-inferiority comparison of Target Lesion Failure (TLF) in the NEVO group to the CYPHER group in subjects with acute STEMI, diabetes mellitus or multi vessel disease.
Časové okno: 12 months follow-up post-procedure
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TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically-driven target lesion revascularization in the NEVO group compared to the CYPHER group.
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12 months follow-up post-procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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TLF in the NEVO and the CYPHER group
Časové okno: Discharge, 1, 6, and 24 months follow-up post-procedure
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TLF: composite clinical endpoint of cardiac death (death that cannot be attributed to a non-cardiac cause), target vessel-related MI and clinically driven target lesion revascularization
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Discharge, 1, 6, and 24 months follow-up post-procedure
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Prescription and compliance patterns and impact of dual antiplatelet therapy (DAPT) duration on the incidence of the composite endpoint of all death, all MI and all revascularization, its individual components,stent thrombosis (ST) and major bleeding.
Časové okno: Duration throughout the study
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Duration throughout the study
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Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion
Časové okno: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel
Časové okno: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Composite endpoint of all death, all MI, all revascularization and its individual components
Časové okno: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure
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Incidence of ARC (Academic Research Consortium) defined (definite, probably, possible and the composite of definite and probable) early and late and very late stent thrombosis
Časové okno: Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
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Hospital discharge, 1,6, 12 and 24 months follow-up post-procedure
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Major bleeding complications
Časové okno: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
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Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
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Stroke that persists >24 hours
Časové okno: Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
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Stroke (cerebrovascular accident or CVA) defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists >24 hours
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Hospital discharge, 1, 6, 12 and 24 months follow-up post-procedure.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Seung Jung Park, MD, Asan Medical Center
- Vrchní vyšetřovatel: Philip Urban, MD, Clinique La Tour
- Vrchní vyšetřovatel: Expedito Ribeiro, MD, Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EC09-02
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