Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Amsterdam, Países Bajos
- Onze Lieve Vrouwe Gasthuis
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Dordrecht, Países Bajos
- Albert Schweitzer Hospital
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Hilversum, Países Bajos
- Tergooi Hospital
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Leeuwarden, Países Bajos
- Medical center Leeuwarden
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Noord-Holland
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Amsterdam, Noord-Holland, Países Bajos, 1105 AZ
- AMC
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
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Bioresorbable scaffold
Otros nombres:
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Comparador activo: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Target Vessel Failure (TVF)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Device success
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 5 year
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5 year
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Major adverse cardiac events
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 1 year and 2 years
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1 year and 2 years
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Quality of Life Questionnaire (QOL)
Periodo de tiempo: 1 year and 2 years
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1 year and 2 years
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Joanna Wykrzykowska, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Rob de Winter, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Jan Piek, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Jan Tijssen, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Jose Henriques, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Anticipado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Infarto de miocardio
- Infarto
- Enfermedad de la arteria coronaria
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Everolimus
Otros números de identificación del estudio
Otros números de identificación del estudio
- COR 10341
- AIDA trial (Identificador de registro: AIDA trial)
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