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Coronary Artery DiseaseAIDANCT01858077

Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

A study testing ABSORB BVS™ and XIENCE™ in people with Coronary Artery Disease and Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABSORB BVS™ and XIENCE™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,845 participants
Where
5 sitesNetherlands
Study dates
Aug 2013to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • AMC

    Amsterdam, North Holland, 1105 AZ

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Albert Schweitzer Hospital

    Dordrecht

  • TerGooi Hospital

    Hilversum

  • Medical Center Leeuwarden

    Leeuwarden

Other trials in Netherlands

About this study

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.

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.

Being tested
ABSORB BVS™, XIENCE™
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABSORB BVS™Device

    Also called ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold, ABSORB, ABSORB BVS, BVS

    Bioresorbable scaffold

  • XIENCE™Device

    Also called XIENCE PRIME, XIENCE Xpedition, XIENCE, DES

    Drug eluting metallic stent

Study groups in NCT01858077
Study groupRoleWhat they receive
ABSORB BVS™Active comparatorAbbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Receives: Device: ABSORB BVS™
XIENCE™Active comparatorXIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
Receives: Device: XIENCE™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (14)

  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.

    Measured: 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.

    Measured: 1 day

  3. Target vessel failure (TVF)

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

    Measured: 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

    Measured: 30 days, and 1, 2, 3, 4 and 5 years

  5. All revascularizations

    Measured: 5 year

  6. Major adverse cardiac events

    All-cause mortality, any MI, any repeat revascularization

    Measured: 30 days, and 1, 2, 3, 4 and 5 years

  7. All cause mortality

    Measured: 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

    Measured: 30 days, 1, 2, 3, 4 and 5 years

  9. Target Lesion Revascularization (TLR)

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

  10. Target Vessel Revascularization (TVR)

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

  11. Non-Target Vessel Revascularization (NTVR)

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

  12. Scaffold/Stent Thrombosis

    acute, subacute, late/definite and probable

    Measured: 30 days, 1, 2, 3, 4 and 5 years

  13. Seattle Angina Questionnaire (SAQ)

    Measured: 1 year and 2 years

  14. Quality of Life Questionnaire (QOL)

    Measured: 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2017
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,845 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01858077
Sponsor's protocol ID
COR 10341
Other IDs
AIDA trial
Acronym
AIDA
Status last verified
Jan 2019
First submitted
10 May 2013
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing ABSORB BVS™ and XIENCE™ in people with Coronary Artery Disease and Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (TVF) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858077, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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