search
Back to results

Angiography Versus (vs) IVUS Optimisation (AVIO)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IVUS optimised DES implantation
angiographically guided DES implantation
Sponsored by
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Patients with at least one complex lesion suitable for implantation of a drug-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion

Exclusion Criteria:

  • Contra-indication to dual anti-platelet therapy.
  • Ejection fraction <30%.
  • Renal failure (creatinine >2 mg/dL).
  • Significant co-morbidity precluding clinical follow-up.
  • Acute myocardial infarction in the 48 hours prior to the procedure.
  • In-stent restenosis
  • Prior brachytherapy
  • Thrombocytopenia <100,000
  • Unprotected left main stem stenosis
  • Venous or arterial grafts
  • Recipient of heart transplant
  • A positive pregnancy test in women with child bearing potential
  • Acute infections
  • Major surgery planned which will lead to discontinuation of antiplatelet therapy
  • Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
  • Age under 18 years old.
  • There is no maximum number of lesions which can be treated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IVUS optimised stent implantation

    angiographically guided DES implantation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.

    Secondary Outcome Measures

    Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
    Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.
    MACE events at 2 years.

    Full Information

    First Posted
    July 8, 2009
    Last Updated
    February 20, 2012
    Sponsor
    Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
    Collaborators
    Mediolanum Cardio Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00936169
    Brief Title
    Angiography Versus (vs) IVUS Optimisation
    Acronym
    AVIO
    Official Title
    Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
    Collaborators
    Mediolanum Cardio Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction
    Keywords
    Patients with at least one complex lesion suitable for implantation of a drug-eluting stent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    284 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IVUS optimised stent implantation
    Arm Type
    Experimental
    Arm Title
    angiographically guided DES implantation
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    IVUS optimised DES implantation
    Intervention Description
    Ivus optimised stent implantation
    Intervention Type
    Procedure
    Intervention Name(s)
    angiographically guided DES implantation
    Intervention Description
    angiographically guided DES implantation
    Primary Outcome Measure Information:
    Title
    Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
    Time Frame
    Procedure day
    Secondary Outcome Measure Information:
    Title
    Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
    Time Frame
    9 months
    Title
    Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.
    Time Frame
    9 months
    Title
    MACE events at 2 years.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion Exclusion Criteria: Contra-indication to dual anti-platelet therapy. Ejection fraction <30%. Renal failure (creatinine >2 mg/dL). Significant co-morbidity precluding clinical follow-up. Acute myocardial infarction in the 48 hours prior to the procedure. In-stent restenosis Prior brachytherapy Thrombocytopenia <100,000 Unprotected left main stem stenosis Venous or arterial grafts Recipient of heart transplant A positive pregnancy test in women with child bearing potential Acute infections Major surgery planned which will lead to discontinuation of antiplatelet therapy Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event Age under 18 years old. There is no maximum number of lesions which can be treated

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23237135
    Citation
    Chieffo A, Latib A, Caussin C, Presbitero P, Galli S, Menozzi A, Varbella F, Mauri F, Valgimigli M, Arampatzis C, Sabate M, Erglis A, Reimers B, Airoldi F, Laine M, Palop RL, Mikhail G, Maccarthy P, Romeo F, Colombo A. A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial. Am Heart J. 2013 Jan;165(1):65-72. doi: 10.1016/j.ahj.2012.09.017. Epub 2012 Nov 20.
    Results Reference
    derived

    Learn more about this trial

    Angiography Versus (vs) IVUS Optimisation

    We'll reach out to this number within 24 hrs