The OPTIMAL Randomized Controlled Trial (NCT04111770) | Clinical Trial Compass
CompletedNot Applicable
The OPTIMAL Randomized Controlled Trial
Italy806 participantsStarted 2020-07-08
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient must be ≥ 18 years of age;
✓. De novo lesion in an unprotected left main coronary artery (ULMCA; ostial, shaft or distal) OR ostial left anterior descending artery (LAD) or ostial circumflex (LCX), both compatible with one Medina class of LM disease; or ostial intermediate branch disease;
✓. PCI is considered appropriate and feasible by the treating interventionalist;
✓. 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;
✕. Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
✕. IVUS is strictly required for pre-PCI lesion severity assessment