Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study
12. oktober 2020 opdateret af: Yonsei University
The investigator aimed to evaluate the long-term (up to 10 years) follow-up of the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions), which was shown the superiority of IVUS-guided stent implantation at 1 year in terms of major adverse cardiac events.
Studieoversigt
Status
Rekruttering
Detaljeret beskrivelse
The investigator will follow-up (up to 10 years) the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions).
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1400
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Myeong-Ki Hong, PhD
- Telefonnummer: 82-2-2228-8460
- E-mail: mkhong61@yuhs.ac
Studiesteder
-
-
-
Seoul, Korea, Republikken, 120-752
- Rekruttering
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
-
Kontakt:
- MYEONG-KI HONG, MD, Ph.D
- Telefonnummer: 82-2-2228-8460
- E-mail: MKHONG61@yuhs.ac
-
-
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
20 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The patients who enrolled in the previous IVUS-XPL study.
In the IVUS-XPL trial, the patients who implatned drug-eluting stents because of ischemic heart disease (stable angina, acute coronay syndrome) were enrolled.
Beskrivelse
Inclusion Criteria:
- 1. The patients who enrolled in the XPL-IVUS study.
- 2. Provision of informed consent
Exclusion Criteria:
- 1. This observational study does not have any specific exclusion criteria.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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IVUS-guidance group
The patients who underwent drug-eluting stents implantation with IVUS guidance.
|
|
Angiography-guidance group
The patients who underwent drug-eluting stents implantation with angiography guidance without IVUS.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years
Tidsramme: At 5 years
|
Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization.
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At 5 years
|
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The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years
Tidsramme: At 10 years
|
Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization.
|
At 10 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac death at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
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At 5 years
|
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Cardiac death at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
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All-cause of death at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
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All-cause of death at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
|
Target-lesion related myocardial infarction at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
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Target-lesion related myocardial infarction at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
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Any myocardial infarction at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
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Any myocardial infarction at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
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At 10 years
|
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Target-lesion revascularization at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
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Target-lesion revascularization at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
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Any revascularization at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
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Any revascularization at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
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Target-lesion related stent thrombosis at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
|
Target-lesion related stent thrombosis at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
|
Any stent thrombosis at 5 years
Tidsramme: At 5 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 5 years
|
|
Any stent thrombosis at 10 years
Tidsramme: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Myeong-Ki Hong, PhD, Severance 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.
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)
15. marts 2019
Primær færdiggørelse (Forventet)
31. juli 2024
Studieafslutning (Forventet)
31. januar 2025
Datoer for studieregistrering
Først indsendt
4. marts 2019
Først indsendt, der opfyldte QC-kriterier
5. marts 2019
Først opslået (Faktiske)
7. marts 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4-2018-1153
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