Myocardial Infarction
Conditions
Keywords
Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
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
Interventions
PROCEDUREIVUS optimised DES implantation
Ivus optimised stent implantation
PROCEDUREangiographically guided DES implantation
angiographically guided DES implantation
Sponsors
Mediolanum Cardio Research
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group. | Procedure day |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group | 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. | 9 months |
| MACE events at 2 years. | 2 years |
Outcome results
None listed