RESOLUTE China Registry: (R-C Registry)
4. april 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1800
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Beijing, Kina, 100000
- Beijing Fumwai Hospital
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Beijing, Kina, 100044
- Peiking University People's Hospital
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Fuzhou, Kina, 350001
- Fujian Medical University Union Hospital
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Guangdong, Kina, 510000
- Guangdong Provincial People's Hospital
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Nanjing, Kina, 210006
- Nanjing First Hospital
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Wuhan, Kina, 430022
- Wuhan Asia Heart Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Target lesion failure (TLF)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall stent thrombosis
Tidsramme: 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
Tidsramme: At the end of the index procedure or during hospital stay
|
At the end of the index procedure or during hospital stay
|
|
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TLF
Tidsramme: 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)
Tidsramme: 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
|
|
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Stent thrombosis rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jiyan Chen, MD, Guangdong Provincial People's Hospital
- Hovedetterforsker: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
- Hovedetterforsker: Lianglong Chen, MD, Fujian Medical University Union Hospital
- Hovedetterforsker: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
- Hovedetterforsker: Weimin Wang, MD, Peiking University People's Hospital
- Hovedetterforsker: Guoying Zhu, MD, Wuhan Asia Heart Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2010
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
15. desember 2017
Datoer for studieregistrering
Først innsendt
17. november 2010
Først innsendt som oppfylte QC-kriteriene
17. november 2010
Først lagt ut (Anslag)
18. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IP124
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