Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1845 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Coronary Artery Disease Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ABSORB BVS™

Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

Group Type ACTIVE_COMPARATOR

ABSORB BVS™

Intervention Type DEVICE

Bioresorbable scaffold

XIENCE™

XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system

Group Type ACTIVE_COMPARATOR

XIENCE™

Intervention Type DEVICE

Drug eluting metallic stent

Interventions

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ABSORB BVS™

Bioresorbable scaffold

Intervention Type DEVICE

XIENCE™

Drug eluting metallic stent

Intervention Type DEVICE

Other Intervention Names

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ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold ABSORB ABSORB BVS BVS XIENCE PRIME XIENCE Xpedition XIENCE DES Drug eluting stent

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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J.J. Wykrzykowska

J.J. Wykrzykowska, MD, PhD, Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR