Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

806

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach

3 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

First Submitted

Initial submission to the registry

September 30, 2019

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed

9 months until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

September 30, 2019

Last Update Submit

February 3, 2026

Conditions

Left Main Coronary Artery Stenosis

Keywords

IVUSPCILeft MainQCATreatment Strategy

Outcome Measures

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.
2-5 years follow up

Secondary Outcomes (7)

Device-oriented Composite Endpoint (DoCE)
2-5 years follow up
Vessel-oriented Composite Endpoint (VoCE)
2-5 years follow up
Patient-oriented Composite Endpoint (POCE)
2 year follow up
All individual components of PoCE at all time points.
2-5 years follow-up
All individual components of DoCE at all time points.
2-5 years follow-up
+2 more secondary outcomes

Study Arms (2)

IVUS guided PCI

EXPERIMENTAL

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

Angiography-guided PCI

ACTIVE COMPARATOR

Qualitative or quantitative angiography will be used to determine lesion characteristics

Device: Qualitative or quantitative angiography will guide percutaneous coronary intervention

Interventions

Qualitative or quantitative angiography will guide percutaneous coronary interventionDEVICE

Qualitative or quantitative angiography will be used to determine lesion characteristics

Angiography-guided PCI

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.

IVUS guided PCI

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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;
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

ECRI bvlead
Philips Healthcarecollaborator
Boston Scientific Corporationcollaborator
Cardialysis B.V.collaborator

Study Sites (28)

ASST Papa Giovanni XXIII

Bergamo, Italy

Location

A.O.U. di Ferrara

Ferrara, Italy

Location

Interventistica Cardiologica Strutturale

Florence, Italy

Location

ASST Niguarda

Milan, Italy

Location

Policlinco San Donato

Milan, Italy

Location

Sant'Ambrogio Clinical Institute

Milan, Italy

Location

Policlinico Umberto I

Rome, Italy

Location

AOUI Verona

Verona, Italy

Location

Hospital Universitario de A Coruña

A Coruña, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Vall d´Hebron

Barcelona, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

Hospital de Cabueñes

Gijón, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Clinico Universiatrio V. Arrixaca

Murcia, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Clinico Lozano Blesa

Zaragoza, Spain

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Royal Sussex Country Hospital

Brighton, United Kingdom

Location

Bristol Royal infirmary

Bristol, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

The Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (2)

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.
PMID: 34995276RESULT
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 Mar 30. doi: 10.1056/NEJMoa2600440. Online ahead of print.
PMID: 41911017DERIVED

Study Officials

Adrian Banning, Prof
Oxford University Hospitals NHS Trust
PRINCIPAL INVESTIGATOR
Luca Testa, Dr.
Policlinco San Donato
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 1, 2019

Study Start

July 8, 2020

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing: Will not share

Locations

ES(10)GB(10)IT(8)

The OPTIMAL Randomized Controlled Trial

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

IVUS guided PCI

Angiography-guided PCI

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (28)

Related Publications (2)

Related Links

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

IVUS guided PCI

Angiography-guided PCI

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (28)

Related Publications (2)

Related Links

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations