At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial
In Brief
A clinical study evaluating IVUS guided Percutaneous Coronary Intervention and Qualitative or quantitative angiography will guide percutaneous coronary intervention for Left Main Coronary Artery Stenosis. Completed, enrolled 806 participants across 28 sites in 3 countries.
Detailed 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).
Study Details
Timeline
Arms & Interventions
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
Interventions
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