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Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion

12. februar 2013 opdateret af: Hyeon-Cheol Gwon, Samsung Medical Center
The purpose of this study is to establish the optimal strategy for side branch stenting in coronary bifurcation lesion.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to evaluate the relative efficacy and safety of conservative strategy compared to aggressive strategy for side branch stenting in coronary bifurcation lesion.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

258

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

Beskrivelse

Inclusion Criteria:

  • Parent vessel diameter stenosis > 75%
  • Parent vessel diameter stenosis 50% - 75% with angina and/or objective evidence of ischemia in the non-invasive stress test
  • The reference diameter of both branches more than 2.3 mm by visual estimation

Exclusion Criteria:

  • Cardiogenic shock
  • ST-elevation myocardial infarction within 48 hours of symptom onset
  • Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
  • Graft vessels
  • Patients who have to receive clopidogrel due to other conditions
  • Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
  • Hypersensitivity to clopidogrel or aspirin
  • Expectant survival less than 1 year
  • Women who plan to become pregnant
  • Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

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
Eksperimentel: Conservative strategy
Procedure: Conservative strategy
  • Main vessel stenting was performed.
  • Side branch ballooning and kissing ballooning were done if Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the side branch after main vessel stenting in non-left main bifurcation (non-LM) subgroup, and diameter stenosis (DS) >75% in LM subgroup.
  • Side branch stenting was performed if TIMI flow <3 in the Side branch after ballooning in non-LM subgroup, and DS >50% or dissection in the Side branch after ballooning in LM subgroup.
Eksperimentel: Aggressive strategy
Procedure: Aggressive strategy
  • Main vessel was performed.
  • Side branch ballooning and kissing ballooning were done if DS >75% in the side branch after main vessel stenting in non-LM subgroup, and DS >50% in LM subgroup.
  • Side branch stenting was performed if DS >50% in the side branch after ballooning in non-LM subgroup, and DS >30% or dissection in the side branch after ballooning in LM subgroup.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target vessel failure (TVF)
Tidsramme: 12 months
composite of cardiac death, myocardial infarction, target vessel revascularization
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiac death
Tidsramme: 12 months
All deaths were considered cardiac unless a definite non-cardiac cause could be established.
12 months
Myocardial infarction (MI)
Tidsramme: 12 months
MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.
12 months
Target vessel revascularization (TVR)
Tidsramme: 12 months
TVR was repeat revascularization of the target vessel by PCI or bypass graft surgery.
12 months
Target lesion revascularization (TLR)
Tidsramme: 12 months
TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
12 months
Stent thrombosis
Tidsramme: 12 months
Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
12 months
Periprocedural enzyme elevation
Tidsramme: during the hospitalization
Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
during the hospitalization
the incidence of binary angiographic restenosis in the main branch and side branch
Tidsramme: 9 months
as measured by 9-month quantitative coronary analysis
9 months

Samarbejdspartnere og efterforskere

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

Sponsor

Samsung Medical Center

Efterforskere

  • Ledende efterforsker: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center

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

1. november 2007

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

17. november 2008

Først indsendt, der opfyldte QC-kriterier

17. november 2008

Først opslået (Skøn)

19. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2007-08-073

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 .

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