Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Device: ABSORB BVS™
* Device: XIENCE™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABSORB BVS™<br>Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System | Device: ABSORB BVS™<br>* Bioresorbable scaffold<br>* Other names: BVS;|
| Active Comparator: XIENCE™<br>XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system | Device: XIENCE™<br>* Drug eluting metallic stent<br>* Other names: Drug eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | 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. | 1 day | 
| Procedural success | 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 | 
| Target vessel failure (TVF) | 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 | 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 |  | 5 year | 
| Major adverse cardiac events | All-cause mortality, any MI, any repeat revascularization | 30 days, and 1, 2, 3, 4 and 5 years | 
| All cause mortality |  | 30 days, 1 year, 2, 3, 4 and 5 years | 
| Myocardial Infarction | 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) |  | 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 | acute, subacute, late/definite and probable | 30 days, 1, 2, 3, 4 and 5 years | 
| Seattle Angina Questionnaire (SAQ) |  | 1 year and 2 years | 
| Quality of Life Questionnaire (QOL) |  | 1 year and 2 years |