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CompletedNCT04111770OPTIMALUpdated Jun 23, 2026

The OPTIMAL Randomized Controlled Trial

An interventional study of IVUS guided Percutaneous Coronary Intervention and Qualitative or quantitative angiography will guide percutaneous coronary intervention in Left Main Coronary Artery Stenosis, sponsored by ECRI bv. Completed at 28 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by ECRI bv · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
806
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Left Main Coronary Artery Stenosis

Keywords

  • IVUS
  • PCI
  • Left Main
  • QCA
  • Treatment Strategy
03

In context

Lead sponsor

ECRI bv is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
  11. Non-cardiac co-morbidities with a life expectancy less than 2 years;
  12. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
806 participants (actual)

Study arms

  • Experimental
    IVUS guided PCI

    Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.

    Device: IVUS guided Percutaneous Coronary Intervention

  • Active comparator
    Angiography-guided PCI

    Qualitative or quantitative angiography will be used to determine lesion characteristics

    Device: Qualitative or quantitative angiography will guide percutaneous coronary intervention

Interventions

  • DeviceIVUS guided Percutaneous Coronary Intervention

    Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.

  • DeviceQualitative or quantitative angiography will guide percutaneous coronary intervention

    Qualitative or quantitative angiography will be used to determine lesion characteristics

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2-5 years follow up

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 2 year follow up

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

    All individual components of PoCE at all time points.

    Time frame: 2-5 years follow-up

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

    All individual components of DoCE at all time points.

    Time frame: 2-5 years follow-up

  6. Definite and probable stent thrombosis

    Definite and probable stent thrombosis according to ARC definition

    Time frame: 2-5 years follow-up

  7. Hospitalization for heart failure

    Investigator reported hospitalization for heart failure

    Time frame: 2-5 years follow-up

07

Study locations

28 sites
  • 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
  • Hospital Vall d´Hebron
    Barcelona, Spain
  • Hospital Reina Sofia
    Córdoba, Spain
  • Hospital de Cabueñes
    Gijón, Spain
  • Hospital Clinico San Carlos
    Madrid, Spain
  • Hospital Clinico Universiatrio V. Arrixaca
    Murcia, Spain
  • Hospital Universitario Marqués de Valdecilla
    Santander, Spain
  • Hospital Alvaro Cunqueiro
    Vigo, Spain
  • Hospital Clinico Lozano Blesa
    Zaragoza, Spain
  • Royal Victoria Hospital
    Belfast, United Kingdom
  • Royal Bournemouth Hospital
    Bournemouth, United Kingdom
  • Royal Sussex Country Hospital
    Brighton, United Kingdom
  • Bristol Royal infirmary
    Bristol, United Kingdom
  • University Hospital of Wales
    Cardiff, United Kingdom
  • Golden Jubilee National Hospital
    Clydebank, United Kingdom
  • Leeds General Infirmary
    Leeds, United Kingdom
  • St Bartholomew's Hospital
    London, United Kingdom
  • The Freeman Hospital
    Newcastle upon Tyne, United Kingdom
  • John Radcliffe Hospital
    Oxford, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04111770
Lead sponsor
ECRI bv
Collaborators
Philips Healthcare, Boston Scientific Corporation, Cardialysis B.V.
Responsible party
Sponsor
First posted
Oct 1, 2019
Start date
Jul 8, 2020
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Jun 23, 2026

Study contacts

Adrian Banning, Prof
principal investigator · Oxford University Hospitals NHS Trust
Luca Testa, Dr.
principal investigator · Policlinco San Donato

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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