Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial
- Conditions
- Coronary Artery DiseaseMyocardial Infarction
- Interventions
- Device: ABSORB BVS™Device: XIENCE™
- Registration Number
- NCT01858077
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1845
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABSORB BVS™ ABSORB BVS™ Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System XIENCE™ XIENCE™ XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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.
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 Target Lesion Revascularization (TLR) 30 days, 1 year, 2, 3, 4 and 5 years 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
Target Vessel Revascularization (TVR) 30 days, 1 year, 2, 3, 4 and 5 years All revascularizations 5 year Scaffold/Stent Thrombosis 30 days, 1, 2, 3, 4 and 5 years acute, subacute, late/definite and probable
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
Non-Target Vessel Revascularization (NTVR) 30 days, 1 year, 2, 3, 4 and 5 years Seattle Angina Questionnaire (SAQ) 1 year and 2 years
Trial Locations
- Locations (5)
Albert Schweitzer Hospital
🇳🇱Dordrecht, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
TerGooi Hospital
🇳🇱Hilversum, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
AMC
🇳🇱Amsterdam, Noord-Holland, Netherlands