The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure for the last enrolled patient. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and yearly after (outpatient clinic visit or telephone call).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
806
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
Qualitative or quantitative angiography will be used to determine lesion characteristics
ASST Papa Giovanni XXIII
Bergamo, Italy
Patient-oriented Composite Endpoint (POCE)
Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)\*, any clinically indicated revascularization at longest follow-up.
Time frame: 2-5 years follow up
Device-oriented Composite Endpoint (DoCE)
Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at longest follow-up
Time frame: 2-5 years follow up
Vessel-oriented Composite Endpoint (VoCE)
Vessel-oriented Composite Endpoint (VoCE) defined as the composite of: left main related cardiac death, target vessel MI, clinically indicated -repeat revascularization of the left main vessels at longest follow-up.
Time frame: 2-5 years follow up
Patient-oriented Composite Endpoint (POCE)
Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)\*, any clinically indicated revascularization at 2 years follow-up.
Time frame: 2 year follow up
All individual components of PoCE at all time points.
All individual components of PoCE at all time points.
Time frame: 2-5 years follow-up
All individual components of DoCE at all time points.
All individual components of DoCE at all time points.
Time frame: 2-5 years follow-up
Definite and probable stent thrombosis
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A.O.U. di Ferrara
Ferrara, Italy
Interventistica Cardiologica Strutturale
Florence, Italy
ASST Niguarda
Milan, Italy
Policlinco San Donato
Milan, Italy
Sant'Ambrogio Clinical Institute
Milan, Italy
Policlinico Umberto I
Rome, Italy
AOUI Verona
Verona, Italy
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital de Bellvitge
Barcelona, Spain
...and 18 more locations
Definite and probable stent thrombosis according to ARC definition
Time frame: 2-5 years follow-up
Hospitalization for heart failure
Investigator reported hospitalization for heart failure
Time frame: 2-5 years follow-up