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The OPTIMAL Randomized Controlled Trial | Clinical Trials | Clareo Health

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The OPTIMAL Randomized Controlled Trial

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

NCT04111770•ECRI bv

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient must be ≥ 18 years of age;
•2. 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;
•3. PCI is considered appropriate and feasible by the treating interventionalist;
•4. Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI;
•5. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.
•Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included.

Exclusion Criteria

•1. Patient is a woman who is pregnant or nursing;
•2. 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);
•3. IVUS is strictly required for pre-PCI lesion severity assessment
•4. ST-elevation myocardial infarction, cardiogenic shock;
•5. Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX;
•6. Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment;
•7. Prior PCI of any other (i.e. non-LM, non-ostial-LAD and non-ostial-LCX) coronary artery lesions within 30 days prior to enrollment;
•8. Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
•9. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
•10. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment;
+2 more criteria

Locations (28)

ASST Papa Giovanni XXIII

Bergamo, Italy

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

Key Dates

Start Date

July 8, 2020

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

February 6, 2026

Enrollment

806

ACTUAL participants

Conditions

Left Main Coronary Artery Stenosis

Interventions

IVUS guided Percutaneous Coronary Intervention

DEVICE

Qualitative or quantitative angiography will guide percutaneous coronary intervention

DEVICE

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

NCT03767621

Coronary Artery DiseaseLeft Main Coronary Artery Stenosis+2 more

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UNKNOWN

eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries

NCT02765646

Left Main Coronary Artery Stenosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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