Overview

This trial is active, not recruiting.

Conditions coronary artery disease, myocardial infarction
Treatments absorb bvs™, xience™
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date August 2013
End date December 2017
Trial size 1850 participants
Trial identifier NCT01858077, AIDA trial, COR 10341

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
absorb bvs™ ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold
Bioresorbable scaffold
(Active Comparator)
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
xience™ XIENCE PRIME
Drug eluting metallic stent

Primary Outcomes

Measure
Target Vessel Failure (TVF)
time frame: 2 years

Secondary Outcomes

Measure
Device success
time frame: 1 day
Procedural success
time frame: 1 day
Target vessel failure (TVF)
time frame: 30 days, and 1, 3, 4 and 5 years
Target lesion failure
time frame: 30 days, and 1, 2, 3, 4 and 5 years
All revascularizations
time frame: 5 year
Major adverse cardiac events
time frame: 30 days, and 1, 2, 3, 4 and 5 years
All cause mortality
time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Myocardial Infarction
time frame: 30 days, 1, 2, 3, 4 and 5 years
Target Lesion Revascularization (TLR)
time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Target Vessel Revascularization (TVR)
time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Non-Target Vessel Revascularization (NTVR)
time frame: 30 days, 1 year, 2, 3, 4 and 5 years
Scaffold/Stent Thrombosis
time frame: 30 days, 1, 2, 3, 4 and 5 years
Seattle Angina Questionnaire (SAQ)
time frame: 1 year and 2 years
Quality of Life Questionnaire (QOL)
time frame: 1 year and 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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.
Principal investigator Rob de Winter, MD, PhD
Description The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 2690 subjects will be enrolled with broad inclusion and limited exclusion criteria. The study population will include 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).