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RESOLUTE China Registry: (R-C Registry)

4. april 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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:

  1. Age ≥ 18 years or minimum age as required by local regulations
  2. 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
  3. 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
  4. Intention to electively implant at least one Resolute stent
  5. 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:

  1. 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
  2. Women with known pregnancy or who are lactating
  3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
  5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
  6. Previous enrollment in the Resolute China Registry

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
12m

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
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
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)
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
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Vascular

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2010

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

15. december 2017

Datoer for studieregistrering

Først indsendt

17. november 2010

Først indsendt, der opfyldte QC-kriterier

17. november 2010

Først opslået (Skøn)

18. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IP124

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