- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01858077
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)
8. januar 2019 opdateret af: J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA Trial): A Clinical Evaluation Comparing the Efficacy and Performance of ABSORB™ Everolimus Eluting Bioresorbable Vascular Scaffold Strategy Versus the XIENCE Family (XIENCE PRIME™ or XIENCE Xpedition™) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers.
To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial.
A total of 1845 patients were enrolled.
The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients.
The follow-up will continue for 5 years including clinical endpoint characteristics.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1845
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Amsterdam, Holland
- Onze Lieve Vrouwe Gasthuis
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Dordrecht, Holland
- Albert Schweitzer Hospital
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Hilversum, Holland
- Tergooi Hospital
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Leeuwarden, Holland
- Medical Center Leeuwarden
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Noord-Holland
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Amsterdam, Noord-Holland, Holland, 1105 AZ
- AMC
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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:
- Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.
- Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Exclusion Criteria:
- Subject is younger than 18 years of age
- Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- Unsuccessful predilation of one or more of the planned lesion to be treated.
- Planned treatment of in-stent restenosis of a previously placed metallic stent.
- Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.
- Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
- Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
- Subjects with a limited life expectancy less than one year.
- Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
- Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
- Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
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Bioresorbable scaffold
Andre navne:
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Aktiv komparator: XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
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Drug eluting metallic stent
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Target Vessel Failure (TVF)
Tidsramme: 2 years
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The primary composite endpoint is the device-oriented composite of target vessel failure (TVF):
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Device success
Tidsramme: 1 day
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Successful delivery and deployment of the first study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 20% by quantitative coronary angiography (QCA) and thrombolysis in myocardial infarction (TIMI) 3 flow grade of the treated vessel.
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1 day
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Procedural success
Tidsramme: 1 day
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Achievement of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat Target Lesion Revascularization during the hospital stay.
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1 day
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Target vessel failure (TVF)
Tidsramme: 30 days, and 1, 3, 4 and 5 years
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Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization
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30 days, and 1, 3, 4 and 5 years
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Target lesion failure
Tidsramme: 30 days, and 1, 2, 3, 4 and 5 years
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Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization
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30 days, and 1, 2, 3, 4 and 5 years
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All revascularizations
Tidsramme: 5 year
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5 year
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Major adverse cardiac events
Tidsramme: 30 days, and 1, 2, 3, 4 and 5 years
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All-cause mortality, any MI, any repeat revascularization
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30 days, and 1, 2, 3, 4 and 5 years
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All cause mortality
Tidsramme: 30 days, 1 year, 2, 3, 4 and 5 years
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30 days, 1 year, 2, 3, 4 and 5 years
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Myocardial Infarction
Tidsramme: 30 days, 1, 2, 3, 4 and 5 years
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Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI
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30 days, 1, 2, 3, 4 and 5 years
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Target Lesion Revascularization (TLR)
Tidsramme: 30 days, 1 year, 2, 3, 4 and 5 years
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30 days, 1 year, 2, 3, 4 and 5 years
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Target Vessel Revascularization (TVR)
Tidsramme: 30 days, 1 year, 2, 3, 4 and 5 years
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30 days, 1 year, 2, 3, 4 and 5 years
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Non-Target Vessel Revascularization (NTVR)
Tidsramme: 30 days, 1 year, 2, 3, 4 and 5 years
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30 days, 1 year, 2, 3, 4 and 5 years
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Scaffold/Stent Thrombosis
Tidsramme: 30 days, 1, 2, 3, 4 and 5 years
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acute, subacute, late/definite and probable
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30 days, 1, 2, 3, 4 and 5 years
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Seattle Angina Questionnaire (SAQ)
Tidsramme: 1 year and 2 years
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1 year and 2 years
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Quality of Life Questionnaire (QOL)
Tidsramme: 1 year and 2 years
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1 year and 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Joanna Wykrzykowska, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: Rob de Winter, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: Jan Piek, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: Jan Tijssen, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Ledende efterforsker: Jose Henriques, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
- Woudstra P, Grundeken MJ, Kraak RP, Hassell ME, Arkenbout EK, Baan J Jr, Vis MM, Koch KT, Tijssen JG, Piek JJ, de Winter RJ, Henriques JP, Wykrzykowska JJ. Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J. 2014 Feb;167(2):133-40. doi: 10.1016/j.ahj.2013.09.017. Epub 2013 Oct 17.
- Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, van der Schaaf RJ, Arkenbout EK, Weevers APJD, Garcia-Garcia HM, Kraak R, Piek JJ, Tijssen JGP, Henriques JPS, de Winter RJ, Wykrzykowska JJ. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial. EuroIntervention. 2022 Mar 18;17(16):1340-1347. doi: 10.4244/EIJ-D-21-00419.
- Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RYG, Koch KT, Baan J Jr, Vis MM, de Winter RJ, Piek JJ, Tijssen JGP, Henriques JPS; AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017 Jun 15;376(24):2319-2328. doi: 10.1056/NEJMoa1614954. Epub 2017 Mar 29.
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. august 2013
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
10. maj 2013
Først indsendt, der opfyldte QC-kriterier
16. maj 2013
Først opslået (Skøn)
21. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Iskæmi
- Patologiske processer
- Nekrose
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Myokardieinfarkt
- Infarkt
- Koronararteriesygdom
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Everolimus
Andre undersøgelses-id-numre
- COR 10341
- AIDA trial (Registry Identifier: AIDA trial)
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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