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Angiography Versus (vs) IVUS Optimisation (AVIO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936169
First Posted: July 9, 2009
Last Update Posted: February 22, 2012
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.
Collaborator:
Mediolanum Cardio Research
Information provided by (Responsible Party):
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
  Purpose
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 Intervention
Myocardial Infarction Procedure: IVUS optimised DES implantation Procedure: angiographically guided DES implantation

Study Type: Interventional
Study Design: 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

Further study details as provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:

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

Secondary Outcome Measures:
  • Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group [ Time Frame: 9 months ]
  • 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 ]
  • MACE events at 2 years. [ Time Frame: 2 years ]

Enrollment: 284
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier: NCT00936169     History of Changes
Other Study ID Numbers: AVIO
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: February 22, 2012
Last Verified: July 2009

Keywords provided by Fondazione Mediolanum 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:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases


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