Angiography Versus (vs) IVUS Optimisation (AVIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936169
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : February 22, 2012
Mediolanum Cardio Research
Information provided by (Responsible Party):
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

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

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: IVUS optimised DES implantation Procedure: angiographically guided DES implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: IVUS optimised stent implantation Procedure: IVUS optimised DES implantation
Ivus optimised stent implantation
Active Comparator: angiographically guided DES implantation Procedure: angiographically guided DES implantation
angiographically guided DES implantation

Primary Outcome Measures :
  1. Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group. [ Time Frame: Procedure day ]

Secondary Outcome Measures :
  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 ]

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS Identifier: NCT00936169     History of Changes
Other Study ID Numbers: AVIO
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: July 2009

Keywords provided by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS:
Patients with at least one complex lesion suitable for implantation of a drug-eluting stent

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases