Angiography Versus (vs) IVUS Optimisation (AVIO)

This study has been completed.
Sponsor:
Collaborator:
Mediolanum Cardio Research-Milan, Italy
Information provided by (Responsible Party):
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier:
NCT00936169
First received: July 8, 2009
Last updated: February 20, 2012
Last verified: July 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus

Additional 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
Study First Received: July 8, 2009
Last Updated: February 20, 2012
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014