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CompletedNCT00936169AVIOUpdated Feb 22, 2012

Angiography Versus (vs) IVUS Optimisation

An interventional study of IVUS optimised DES implantation and angiographically guided DES implantation in Myocardial Infarction, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
284
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's enrollment of 284 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

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

  • 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

Exclusion Criteria:

  • to dual anti- therapy.
  • \<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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
284 participants (actual)

Study arms

  • Experimental
    IVUS optimised stent implantation

    Procedure: IVUS optimised DES implantation

  • Active comparator
    angiographically guided DES implantation

    Procedure: angiographically guided DES implantation

Interventions

  • ProcedureIVUS optimised DES implantation

    Ivus optimised stent implantation

  • Procedureangiographically guided DES implantation

    angiographically guided DES implantation

06

What researchers measure

Primary outcomes

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

    Time frame: Procedure day

Secondary outcomes

  1. Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group

    Time frame: 9 months

  2. 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

  3. MACE events at 2 years.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23237135 ↗
09

Timeline

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

The record gives a start of May 2008, a primary completion of Jun 2009 and a completion of Jul 2011. 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
Jul 8, 2009
First posted
Jul 9, 2009
Start
May 2008
Primary completionActual
Jun 2009
CompletionActual
Jul 2011
Last update
Feb 22, 2012
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 Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00936169
Lead sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators
Mediolanum Cardio Research
Responsible party
Sponsor
First posted
Jul 9, 2009
Start date
May 2008
Primary completion
Jun 2009
Completion
Jul 2011
Last update
Feb 22, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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