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 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Förväntat)
1400
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Myeong-Ki Hong, PhD
- Telefonnummer: 82-2-2228-8460
- E-post: mkhong61@yuhs.ac
Studieorter
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-
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Seoul, Korea, Republiken av, 120-752
- Rekrytering
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
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Kontakt:
- MYEONG-KI HONG, MD, Ph.D
- Telefonnummer: 82-2-2228-8460
- E-post: MKHONG61@yuhs.ac
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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IVUS-guidance group
The patients who underwent drug-eluting stents implantation with IVUS guidance.
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Angiography-guidance group
The patients who underwent drug-eluting stents implantation with angiography guidance without IVUS.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiac death at 5 years
Tidsram: 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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Cardiac death at 10 years
Tidsram: At 10 years
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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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All-cause of death at 5 years
Tidsram: 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
Tidsram: 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 myocardial infarction at 5 years
Tidsram: 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
Tidsram: At 10 years
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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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Any myocardial infarction at 5 years
Tidsram: 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
Tidsram: 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 revascularization at 5 years
Tidsram: 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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Target-lesion revascularization at 10 years
Tidsram: At 10 years
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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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Any revascularization at 5 years
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At 10 years
|
Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events.
|
At 10 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Myeong-Ki Hong, PhD, Severance Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 mars 2019
Primärt slutförande (Förväntat)
31 juli 2024
Avslutad studie (Förväntat)
31 januari 2025
Studieregistreringsdatum
Först inskickad
4 mars 2019
Först inskickad som uppfyllde QC-kriterierna
5 mars 2019
Första postat (Faktisk)
7 mars 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4-2018-1153
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .