Clinical trial NCT00936169: Angiography Versus (vs) IVUS Optimisation
Official title: Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
Lead sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Sponsor class: OTHER
Collaborators: name: Mediolanum Cardio Research
First posted: 2009-07-09
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
timeFrame: Procedure day
Secondary outcomes:
measure: Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
timeFrame: 9 months
measure: 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.
timeFrame: 9 months
measure: MACE events at 2 years.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
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.