Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Unknown

Conditions

Coronary Artery Disease

Myocardial Infarction

Treatments

Device: XIENCE™

Device: ABSORB BVS™

Study type

Interventional

Funder types

Other

Identifiers

NCT01858077

AIDA trial (Registry Identifier)

COR 10341

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,845 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.