Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI
22. januar 2018 opdateret af: Seung-Ho Hur, Keimyung University Dongsan Medical Center
LAte Stent Strut APPosition and COverage After Drug-Eluting Stent ImplantaTIOn by Optical Coherence Tomography in PatieNts With Acute Myocardial Infarction II(APPOSITION-AMI II)
The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release.
Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes.
However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis.
Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).
Undersøgelsestype
Observationel
Tilmelding (Forventet)
69
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Daegu, Korea, Republikken
- Keimyung University Dongsan Medical Center
-
-
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
Sandsynlighedsprøve
Studiebefolkning
Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
Beskrivelse
Inclusion Criteria:
- Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
- Patient ≥ 18 years of age
- Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
- culprit lesion
Exclusion Criteria:
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media
- Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment
- Cardiogenic shock
- Patient with left ventricular ejection fraction <30%
- Patient with left main disease
- Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)
- Patient with impaired renal function (creatinine >2.0mg/dL)
- Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts
- bifucation lesion needs complex procedure with insert two or more Drug eluting stents.
- lesion length >30mm
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 |
Intervention / Behandling |
|---|---|
|
Optical Coherence Tomography
To evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.
|
Everolimus-Eluting stent with bioabsorbable polymer
Andre navne:
Zotarolimus-Eluting stent with permanent polymer
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups
Tidsramme: 12month
|
Incidence of malapposed and uncovered stent strut measured by OCT
|
12month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent neointima cross-sectional area
Tidsramme: 12month
|
By OCT, percentage neointima cross sectional area can be obtained by dividing the neointimal area by the stent area.(neointima
cross-sectional area in mm²(Quadratmillimeter)/sec)
|
12month
|
|
Mean neointima thickness
Tidsramme: 12month
|
By OCT, neointima thickness can be measured as distance from the endoluminal surface of the neointima to the stent strut.(mean
neointima thickness in millimeter)
|
12month
|
|
Morphologic characteristics of neointima
Tidsramme: 12month
|
Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden)
|
12month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Seung-Ho Hur, Postdoctoral, Keimyung University Dongsan 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
- Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
- Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Mintz GS, Gao RL. Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial. EuroIntervention. 2014 Nov;10(7):806-14. doi: 10.4244/EIJY14M07_17.
- Kim S, Kim JS, Shin DH, Kim BK, Ko YG, Choi D, Cho YK, Nam CW, Hur SH, Jang Y, Hong MK. Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. Am J Cardiol. 2013 Jan 1;111(1):1-5. doi: 10.1016/j.amjcard.2012.08.037. Epub 2012 Oct 2. Erratum In: Am J Cardiol. 2013 Sep 1;112(5):746.
- Karjalainen PP, Varho V, Nammas W, Mikkelsson J, Pietila M, Ylitalo A, Airaksinen JK, Sia J, Nyman K, Biancari F, Kiviniemi T. Early neointimal coverage and vasodilator response following biodegradable polymer sirolimus-eluting vs. durable polymer zotarolimus-eluting stents in patients with acute coronary syndrome -HATTRICK-OCT trial. Circ J. 2015;79(2):360-7. doi: 10.1253/circj.CJ-14-1000. Epub 2014 Dec 15.
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. maj 2016
Primær færdiggørelse (Forventet)
1. juni 2018
Studieafslutning (Forventet)
1. december 2018
Datoer for studieregistrering
Først indsendt
1. maj 2016
Først indsendt, der opfyldte QC-kriterier
10. maj 2016
Først opslået (Skøn)
12. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-01-030
- APPOSITION-AMI II (Anden identifikator: Keimyung University Dongsan Medical Center)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
undecided
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 .