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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01858077
First received: May 10, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Coronary Artery Disease
Myocardial Infarction
Device: ABSORB BVS™
Device: XIENCE™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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:
  • Device success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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.

  • Procedural success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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.

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

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

  • All revascularizations [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac events [ Time Frame: 30 days, and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
    All-cause mortality, any MI, any repeat revascularization

  • All cause mortality [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 30 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
    Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI

  • Target Lesion Revascularization (TLR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Non-Target Vessel Revascularization (NTVR) [ Time Frame: 30 days, 1 year, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Scaffold/Stent Thrombosis [ Time Frame: 30 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
    acute, subacute, late/definite and probable

  • Seattle Angina Questionnaire (SAQ) [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire (QOL) [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2690
Study Start Date: August 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABSORB BVS™
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Device: ABSORB BVS™
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™
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition
  • XIENCE
  • DES
  • Drug eluting stent

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858077

Contacts
Contact: Joanna Wykrzykowska, MD, PhD 020 - 566 9111 j.j.wykrzykowska@amc.uva.nl
Contact: Robin Kraak, MD r.p.kraak@amc.uva.nl

Locations
Netherlands
AMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Joanna Wykrzykowska    020 - 566 9111    j.j.Wykrzykowska@amc.uva.nl   
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Netherlands
Contact: R.J van der Schaaf         
TerGooi Hospital Not yet recruiting
Hilversum, Netherlands
Contact: E.K Arkenbout         
Medical Center Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: S.H Hofma         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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: Jose Henriques, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Publications:
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
Study First Received: May 10, 2013
Last Updated: June 24, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 10, 2014