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Left Main Coronary Artery StenosisOPTIMALNCT04111770

The OPTIMAL Randomized Controlled Trial

A study testing IVUS guided Percutaneous Coronary Intervention and Qualitative or quantitative angiography will guide percutaneous coronary intervention in people with Left Main Coronary Artery Stenosis, run by ECRI bv at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Left Main Coronary Artery Stenosis
What is being tested?
IVUS guided Percutaneous Coronary Intervention and Qualitative or quantitative angiography will guide percutaneous coronary intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
806 participants
Where
28 sitesin 3 countries
Study dates
8 Jul 2020to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI;
  • 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.

Who cannot join

  • 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
  • ST-elevation myocardial infarction, cardiogenic shock;
  • Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX;
  • Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment;
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  • 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;
  • 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;
  • Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
  • Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment;
  • Non-cardiac co-morbidities with a life expectancy less than 2 years;
  • Currently participating in another trial that is 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 enrollment.

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

Spain10 sites

  • Hospital Universitario de A Coruña

    A Coruña

  • Hospital de Bellvitge

    Barcelona

  • Hospital Vall d´Hebron

    Barcelona

  • Hospital Reina Sofia

    Córdoba

  • Hospital de Cabueñes

    Gijón

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Clinico Universiatrio V. Arrixaca

    Murcia

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Alvaro Cunqueiro

    Vigo

  • Hospital Clinico Lozano Blesa

    Zaragoza

Other trials in Spain

United Kingdom10 sites

  • Royal Victoria Hospital

    Belfast

  • Royal Bournemouth Hospital

    Bournemouth

  • Royal Sussex Country Hospital

    Brighton

  • Bristol Royal infirmary

    Bristol

  • University Hospital of Wales

    Cardiff

  • Golden Jubilee National Hospital

    Clydebank

  • Leeds General Infirmary

    Leeds

  • St Bartholomew's Hospital

    London

  • The Freeman Hospital

    Newcastle upon Tyne

  • John Radcliffe Hospital

    Oxford

Other trials in United Kingdom

Italy8 sites

  • ASST Papa Giovanni XXIII

    Bergamo

  • A.O.U. di Ferrara

    Ferrara

  • Interventistica Cardiologica Strutturale

    Florence

  • ASST Niguarda

    Milan

  • Policlinco San Donato

    Milan

  • Sant'Ambrogio Clinical Institute

    Milan

  • Policlinico Umberto I

    Rome

  • AOUI Verona

    Verona

Other trials in Italy

About this study

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

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).

Being tested
IVUS guided Percutaneous Coronary Intervention, Qualitative or quantitative angiography will guide percutaneous coronary intervention
Keywords
IVUS, PCI, Left Main, QCA, Treatment Strategy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVUS guided Percutaneous Coronary InterventionDevice

    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 guide percutaneous coronary interventionDevice

    Qualitative or quantitative angiography will be used to determine lesion characteristics

Study groups in NCT04111770
Study groupRoleWhat they receive
IVUS guided PCIExperimentalPre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
Receives: Device: IVUS guided Percutaneous Coronary Intervention
Angiography-guided PCIActive comparatorQualitative or quantitative angiography will be used to determine lesion characteristics
Receives: Device: Qualitative or quantitative angiography will guide percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 longest follow-up.

    Measured: 2-5 years follow up

Secondary outcomes (7)

  1. 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 longest follow-up

    Measured: 2-5 years follow up

  2. 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 longest follow-up.

    Measured: 2-5 years follow up

  3. 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.

    Measured: 2 year follow up

  4. All individual components of PoCE at all time points.

    All individual components of PoCE at all time points.

    Measured: 2-5 years follow-up

  5. All individual components of DoCE at all time points.

    All individual components of DoCE at all time points.

    Measured: 2-5 years follow-up

  6. Definite and probable stent thrombosis

    Definite and probable stent thrombosis according to ARC definition

    Measured: 2-5 years follow-up

  7. Hospitalization for heart failure

    Investigator reported hospitalization for heart failure

    Measured: 2-5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start8 Jul 2020
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111770
Sponsor's protocol ID
ECRI-013
Acronym
OPTIMAL
Status last verified
Feb 2026
First submitted
30 Sep 2019
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Testa L, De la Torre Hernandez JM, De Maria GL, Jones DA, Pinon-Esteban P, Campo G, Garcia Del Blanco B, Pan M, Garcia-Camarero T, Sardella G, O'Kane P, Greenwood JP, Ribichini FL, Pescetelli I, Ielasi A, Lozano I, Cockburn J, Oreglia JA, Zaman AG, Bedogni F, Lindeboom W, Tijssen JGP, Spitzer E, Banning AP; OPTIMAL Investigators. IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease. N Engl J Med. 2026 Jun 11;394(22):2189-2199. doi: 10.1056/NEJMoa2600440. Epub 2026 Mar 30.

    PubMed 41911017

  • De Maria GL, Testa L, de la Torre Hernandez JM, Terentes-Printzios D, Emfietzoglou M, Scarsini R, Bedogni F, Spitzer E, Banning A. A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main coronary artery (ULMCA) disease: Study protocol for OPTIMAL trial. PLoS One. 2022 Jan 7;17(1):e0260770. doi: 10.1371/journal.pone.0260770. eCollection 2022.

    PubMed 34995276

Questions about this trial

What is this clinical trial studying?

A study testing IVUS guided Percutaneous Coronary Intervention and Qualitative or quantitative angiography will guide percutaneous coronary intervention in people with Left Main Coronary Artery Stenosis, run by ECRI bv at 28 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-oriented Composite Endpoint (POCE) (time frame: 2-5 years follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04111770, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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