Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)
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ClinicalTrials.gov Identifier: NCT01858077 |
Recruitment Status : Unknown
Verified January 2019 by J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : January 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease Myocardial Infarction | Device: ABSORB BVS™ Device: XIENCE™ | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1845 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
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Active Comparator: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
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Device: ABSORB BVS™
Bioresorbable scaffold
Other Names:
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Active Comparator: XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
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Device: XIENCE™
Drug eluting metallic stent
Other Names:
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- Target Vessel Failure (TVF) [ Time Frame: 2 years ]
The primary composite endpoint is the device-oriented composite of target vessel failure (TVF):
- Cardiac death
- Myocardial Infarction (MI) (unless clearly attributable to a non target vessel)
- Target vessel revascularization
- Device success [ Time Frame: 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.
- Procedural success [ Time Frame: 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.
- Target vessel failure (TVF) [ Time Frame: 30 days, and 1, 3, 4 and 5 years ]Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization
- Target lesion failure [ Time Frame: 30 days, and 1, 2, 3, 4 and 5 years ]Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization
- All revascularizations [ Time Frame: 5 year ]
- Major adverse cardiac events [ Time Frame: 30 days, and 1, 2, 3, 4 and 5 years ]All-cause mortality, any MI, any repeat revascularization
- All cause mortality [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ]
- Myocardial Infarction [ Time Frame: 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
- Target Lesion Revascularization (TLR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ]
- Target Vessel Revascularization (TVR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ]
- Non-Target Vessel Revascularization (NTVR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ]
- Scaffold/Stent Thrombosis [ Time Frame: 30 days, 1, 2, 3, 4 and 5 years ]acute, subacute, late/definite and probable
- Seattle Angina Questionnaire (SAQ) [ Time Frame: 1 year and 2 years ]
- Quality of Life Questionnaire (QOL) [ Time Frame: 1 year and 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858077
Netherlands | |
AMC | |
Amsterdam, Noord-Holland, Netherlands, 1105 AZ | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands | |
Albert Schweitzer Hospital | |
Dordrecht, Netherlands | |
TerGooi Hospital | |
Hilversum, Netherlands | |
Medical Center Leeuwarden | |
Leeuwarden, Netherlands |
Study Director: | Joanna Wykrzykowska, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Rob de Winter, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Jan Piek, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Jan Tijssen, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Jose Henriques, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | J.J. Wykrzykowska, J.J. Wykrzykowska, MD, PhD, Coordinating Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT01858077 |
Other Study ID Numbers: |
COR 10341 AIDA trial ( Registry Identifier: AIDA trial ) |
First Posted: | May 21, 2013 Key Record Dates |
Last Update Posted: | January 9, 2019 |
Last Verified: | January 2019 |
Coronary Artery Disease Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |