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Status unknownNCT01858077AIDAUpdated Jan 9, 2019

Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

An interventional study of ABSORB BVS™ and XIENCE™ in Coronary Artery Disease and Myocardial Infarction, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,845
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Myocardial Infarction
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 1,845 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.

Browse Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,845 participants (actual)

Study arms

  • Active comparator
    ABSORB BVS™

    Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

    Device: ABSORB BVS™

  • Active comparator
    XIENCE™

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

    Device: XIENCE™

Interventions

  • DeviceABSORB BVS™

    Bioresorbable scaffold

    Also known as: ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold, ABSORB, ABSORB BVS, BVS

  • DeviceXIENCE™

    Drug eluting metallic stent

    Also known as: XIENCE PRIME, XIENCE Xpedition, XIENCE, DES, Drug eluting stent

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. Target vessel failure (TVF)

    Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization

    Time frame: 30 days, and 1, 3, 4 and 5 years

  4. Target lesion failure

    Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization

    Time frame: 30 days, and 1, 2, 3, 4 and 5 years

  5. All revascularizations

    Time frame: 5 year

  6. Major adverse cardiac events

    All-cause mortality, any MI, any repeat revascularization

    Time frame: 30 days, and 1, 2, 3, 4 and 5 years

  7. All cause mortality

    Time frame: 30 days, 1 year, 2, 3, 4 and 5 years

  8. Myocardial Infarction

    Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI

    Time frame: 30 days, 1, 2, 3, 4 and 5 years

  9. Target Lesion Revascularization (TLR)

    Time frame: 30 days, 1 year, 2, 3, 4 and 5 years

  10. Target Vessel Revascularization (TVR)

    Time frame: 30 days, 1 year, 2, 3, 4 and 5 years

  11. Non-Target Vessel Revascularization (NTVR)

    Time frame: 30 days, 1 year, 2, 3, 4 and 5 years

  12. Scaffold/Stent Thrombosis

    acute, subacute, late/definite and probable

    Time frame: 30 days, 1, 2, 3, 4 and 5 years

  13. Seattle Angina Questionnaire (SAQ)

    Time frame: 1 year and 2 years

  14. Quality of Life Questionnaire (QOL)

    Time frame: 1 year and 2 years

07

Study locations

5 sites
  • AMC
    Amsterdam, North Holland 1105 AZ, Netherlands
  • Onze Lieve Vrouwe Gasthuis
    Amsterdam, Netherlands
  • Albert Schweitzer Hospital
    Dordrecht, Netherlands
  • TerGooi Hospital
    Hilversum, Netherlands
  • Medical Center Leeuwarden
    Leeuwarden, Netherlands
08

References and documents

Publications

  • Woudstra P, Grundeken MJ, Kraak RP, Hassell ME, Arkenbout EK, Baan J Jr, Vis MM, Koch KT, Tijssen JG, Piek JJ, de Winter RJ, Henriques JP, Wykrzykowska JJ. 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 vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J. 2014 Feb;167(2):133-40. doi: 10.1016/j.ahj.2013.09.017. Epub 2013 Oct 17. PubMed 24439973 ↗
  • Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, van der Schaaf RJ, Arkenbout EK, Weevers APJD, Garcia-Garcia HM, Kraak R, Piek JJ, Tijssen JGP, Henriques JPS, de Winter RJ, Wykrzykowska JJ. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial. EuroIntervention. 2022 Mar 18;17(16):1340-1347. doi: 10.4244/EIJ-D-21-00419. PubMed 34483094 ↗
  • Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RYG, Koch KT, Baan J Jr, Vis MM, de Winter RJ, Piek JJ, Tijssen JGP, Henriques JPS; AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017 Jun 15;376(24):2319-2328. doi: 10.1056/NEJMoa1614954. Epub 2017 Mar 29. PubMed 28402237 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Dec 2017 and a completion of Dec 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2013
First posted
May 21, 2013
Start
Aug 2013
Primary completionActual
Dec 2017
CompletionEst.
Dec 2020
Last update
Jan 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01858077
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
J.J. Wykrzykowska (J.J. Wykrzykowska, MD, PhD, Coordinating Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
May 21, 2013
Start date
Aug 2013
Primary completion
Dec 2017
Completion
Dec 2020 (estimated)
Last update
Jan 9, 2019

Study contacts

Joanna Wykrzykowska, MD, PhD
study director · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rob de Winter, MD, PhD
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Jan Piek, MD, PhD
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Jan Tijssen, PhD
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Jose Henriques, MD, PhD
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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