Angiography Versus (vs) IVUS Optimisation (AVIO)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IVUS optimised DES implantation
angiographically guided DES implantation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IVUS optimised stent implantation
angiographically guided DES implantation
Arm Description
Outcomes
Primary Outcome Measures
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
Secondary Outcome Measures
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
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.
MACE events at 2 years.
Full Information
NCT ID
NCT00936169
First Posted
July 8, 2009
Last Updated
February 20, 2012
Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators
Mediolanum Cardio Research
1. Study Identification
Unique Protocol Identification Number
NCT00936169
Brief Title
Angiography Versus (vs) IVUS Optimisation
Acronym
AVIO
Official Title
Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Collaborators
Mediolanum Cardio Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVUS optimised stent implantation
Arm Type
Experimental
Arm Title
angiographically guided DES implantation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
IVUS optimised DES implantation
Intervention Description
Ivus optimised stent implantation
Intervention Type
Procedure
Intervention Name(s)
angiographically guided DES implantation
Intervention Description
angiographically guided DES implantation
Primary Outcome Measure Information:
Title
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
Time Frame
Procedure day
Secondary Outcome Measure Information:
Title
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
Time Frame
9 months
Title
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
Title
MACE events at 2 years.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
23237135
Citation
Chieffo A, Latib A, Caussin C, Presbitero P, Galli S, Menozzi A, Varbella F, Mauri F, Valgimigli M, Arampatzis C, Sabate M, Erglis A, Reimers B, Airoldi F, Laine M, Palop RL, Mikhail G, Maccarthy P, Romeo F, Colombo A. A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial. Am Heart J. 2013 Jan;165(1):65-72. doi: 10.1016/j.ahj.2012.09.017. Epub 2012 Nov 20.
Results Reference
derived
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Angiography Versus (vs) IVUS Optimisation
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