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

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ClinicalTrials.gov Identifier: NCT01858077
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Device: ABSORB BVS™ Device: XIENCE™ Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1845 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : August 2013
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
 Device: ABSORB BVS™
Bioresorbable scaffold
Other Names:
  • ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold
  • ABSORB
  • ABSORB BVS
  • BVS
Active Comparator: XIENCE™
XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system
 Device: XIENCE™
Drug eluting metallic stent
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition
  • XIENCE
  • DES
  • Drug eluting stent


Outcome Measures
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Primary Outcome Measures :
  1. Target Vessel Failure (TVF) [ Time Frame: 2 years ]

    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


Secondary Outcome Measures :
  1. Device success [ Time Frame: 1 day ]
    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.

  2. Procedural success [ Time Frame: 1 day ]
    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.

  3. Target vessel failure (TVF) [ Time Frame: 30 days, and 1, 3, 4 and 5 years ]
    Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization

  4. Target lesion failure [ Time Frame: 30 days, and 1, 2, 3, 4 and 5 years ]
    Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization

  5. All revascularizations [ Time Frame: 5 year ]
  6. Major adverse cardiac events [ Time Frame: 30 days, and 1, 2, 3, 4 and 5 years ]
    All-cause mortality, any MI, any repeat revascularization

  7. All cause mortality [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ]
  8. Myocardial Infarction [ Time Frame: 30 days, 1, 2, 3, 4 and 5 years ]
    Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI

  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 [ Time Frame: 30 days, 1, 2, 3, 4 and 5 years ]
    acute, subacute, late/definite and probable

  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858077


Locations
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Netherlands
AMC
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
TerGooi Hospital
Hilversum, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Director: Joanna Wykrzykowska, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Rob de Winter, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Jan Piek, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Jan Tijssen, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Jose Henriques, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: J.J. Wykrzykowska, J.J. Wykrzykowska, MD, PhD, Coordinating Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01858077     History of Changes
Other Study ID Numbers: COR 10341
AIDA trial ( Registry Identifier: AIDA trial )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents