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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014