The OPTIMAL Randomized Controlled Trial (OPTIMAL)

This is an interventional treatment trial for Left Main Coronary Artery Stenosis focused on measuring IVUS, PCI, Left Main, QCA, Treatment Strategy Read More

Inclusion Criteria:

1. The patient must be ≥ 18 years of age;
2. De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*.
3. 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).
4. Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.
5. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.
6. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.

Exclusion Criteria:

1. 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).
2. Ongoing MI or recent MI with cardiac biomarker levels still elevated.
3. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.
4. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.
5. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.
6. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration
7. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.
8. Non-cardiac co-morbidities with a life expectancy less than 2 years.
9. 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.