Coronary Artery Disease, Myocardial Infarction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEABSORB BVS™
Bioresorbable scaffold
DEVICEXIENCE™
Drug eluting metallic stent
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 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) | 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 | 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 | 5 year | — |
| Major adverse cardiac events | 30 days, and 1, 2, 3, 4 and 5 years | All-cause mortality, any MI, any repeat revascularization |
| All cause mortality | 30 days, 1 year, 2, 3, 4 and 5 years | — |
| Device success | 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. |
| Target Lesion Revascularization (TLR) | 30 days, 1 year, 2, 3, 4 and 5 years | — |
| Target Vessel Revascularization (TVR) | 30 days, 1 year, 2, 3, 4 and 5 years | — |
| Non-Target Vessel Revascularization (NTVR) | 30 days, 1 year, 2, 3, 4 and 5 years | — |
| Scaffold/Stent Thrombosis | 30 days, 1, 2, 3, 4 and 5 years | acute, subacute, late/definite and probable |
| Seattle Angina Questionnaire (SAQ) | 1 year and 2 years | — |
| Quality of Life Questionnaire (QOL) | 1 year and 2 years | — |
| Myocardial Infarction | 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 |
Countries
Netherlands
Outcome results
None listed