The OPTIMAL Randomized Controlled Trial

Study Overview
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Brief Summary
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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. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and 24 months (outpatient clinic visit or telephone call) after the index procedure.

Official Title
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OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial

Conditions
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Left Main Coronary Artery Stenosis

Intervention / Treatment
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* Device: IVUS guided Percutaneous Coronary Intervention
* Device: QCA guided Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥ 18 years of age; De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*. Stable or unstable angina, non-ST segment myocardial infarction, documented silent ischemia or a positive functional study (e.g. by pressure or angiography derived indices). Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years. Exclusion Criteria: Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). Ongoing MI or recent MI with cardiac biomarker levels still elevated. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization. Non-cardiac co-morbidities with a life expectancy less than 2 years. Currently participating in another trial and not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrolment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS guided PCI<br>Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent. | Device: IVUS guided Percutaneous Coronary Intervention<br>* Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.<br>|
| Active Comparator: QCA guided PCI<br>QCA will be used to determine lesion characteristics | Device: QCA guided Percutaneous Coronary Intervention<br>* QCA will be used to determine lesion characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 1 and 2 years. | 1 and 2 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 1 and 2 years. | 1 and 2 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. | 1 year follow up | 
| All individual components of PoCE at all time points. | All individual components of PoCE at all time points. | 1 and 2 years follow up | 
| All individual components of DoCE at all time points. | All individual components of DoCE at all time points. | 1 and 2 years follow up | 
| Definite and probable stent thrombosis | Definite and probable stent thrombosis according to ARC definition | 1 and 2 years | 
| Hospitalization for heart failure | Investigator reported hospitalization for heart failure | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVUS, PCI, Left Main, QCA, Treatment Strategy