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OpenTrials
Completed

NCT Number: NCT00936169

Angiography Versus (vs) IVUS Optimisation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVUS optimised DES implantation

Procedure

Ivus optimised stent implantation

angiographically guided DES implantation

Procedure

angiographically guided DES implantation

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

Sponsors and collaborators

Lead sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Other

Collaborators

  • Mediolanum Cardio Research

Registry information

Official study title

Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation

Acronym: AVIO

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Jul 9, 2009
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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