- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01858077
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)
8 januari 2019 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1845
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Amsterdam, Nederländerna
- Onze Lieve Vrouwe Gasthuis
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Dordrecht, Nederländerna
- Albert Schweitzer Hospital
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Hilversum, Nederländerna
- Tergooi Hospital
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Leeuwarden, Nederländerna
- Medical center Leeuwarden
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Noord-Holland
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Amsterdam, Noord-Holland, Nederländerna, 1105 AZ
- AMC
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-
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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
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Bioresorbable scaffold
Andra namn:
|
|
Aktiv komparator: XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
|
Drug eluting metallic stent
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Target Vessel Failure (TVF)
Tidsram: 2 years
|
The primary composite endpoint is the device-oriented composite of target vessel failure (TVF):
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2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Device success
Tidsram: 1 day
|
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
Tidsram: 1 day
|
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.
|
1 day
|
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Target vessel failure (TVF)
Tidsram: 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
|
30 days, and 1, 3, 4 and 5 years
|
|
Target lesion failure
Tidsram: 30 days, and 1, 2, 3, 4 and 5 years
|
Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization
|
30 days, and 1, 2, 3, 4 and 5 years
|
|
All revascularizations
Tidsram: 5 year
|
5 year
|
|
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Major adverse cardiac events
Tidsram: 30 days, and 1, 2, 3, 4 and 5 years
|
All-cause mortality, any MI, any repeat revascularization
|
30 days, and 1, 2, 3, 4 and 5 years
|
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All cause mortality
Tidsram: 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
Tidsram: 30 days, 1, 2, 3, 4 and 5 years
|
Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI
|
30 days, 1, 2, 3, 4 and 5 years
|
|
Target Lesion Revascularization (TLR)
Tidsram: 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)
Tidsram: 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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|
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Non-Target Vessel Revascularization (NTVR)
Tidsram: 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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|
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Scaffold/Stent Thrombosis
Tidsram: 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)
Tidsram: 1 year and 2 years
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1 year and 2 years
|
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Quality of Life Questionnaire (QOL)
Tidsram: 1 year and 2 years
|
1 year and 2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Joanna Wykrzykowska, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Huvudutredare: Rob de Winter, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Huvudutredare: Jan Piek, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Huvudutredare: Jan Tijssen, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Huvudutredare: Jose Henriques, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Allmänna 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.
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
1 augusti 2013
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Förväntat)
1 december 2020
Studieregistreringsdatum
Först inskickad
10 maj 2013
Först inskickad som uppfyllde QC-kriterierna
16 maj 2013
Första postat (Uppskatta)
21 maj 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 januari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Ischemi
- Patologiska processer
- Nekros
- Myokardischemi
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Hjärtinfarkt
- Infarkt
- Kranskärlssjukdom
- Läkemedels fysiologiska effekter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Everolimus
Andra studie-ID-nummer
- COR 10341
- AIDA trial (Registeridentifierare: AIDA trial)
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