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Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography (NeoCover)

19. december 2016 opdateret af: Yu Bo, Harbin Medical University

Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography

Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.

However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • The Second Affiliated Hospital of Harbin Medical University

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age: 18-75 years
  • Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
  • Length of culprit lesion≤25mm.
  • Vessel size in between 2.5 and 4.0 mm.
  • Signed patient informed consent.

Exclusion Criteria:

  • Prior administration of thrombolytic therapy.
  • Cardiogenic shock.
  • Renal failure (Crea≥2.0mg/dL).
  • Recent major bleeding.
  • Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
  • Left main disease
  • Multi-vessel lesion
  • Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
  • Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
  • No suitable anatomy for OCT scan.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: DES
Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Enhed: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)
Aktiv komparator: BMS
Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
Enhed: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
Tidsramme: 3-month
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
3-month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Tidsramme: 12-month
The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
12-month
Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Tidsramme: 3-month
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
3-month
Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Tidsramme: 12-month
Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS. The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
12-month
Major adverse cardiovascular events (MACE)
Tidsramme: 12-month
12-month

Samarbejdspartnere og efterforskere

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

Sponsor

Harbin Medical University

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

1. juni 2013

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Forventet)

1. maj 2017

Datoer for studieregistrering

Først indsendt

5. juni 2013

Først indsendt, der opfyldte QC-kriterier

10. juni 2013

Først opslået (Skøn)

12. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HMUOCT-STEMI

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut myokardieinfarkt

Kliniske forsøg med Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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