The OPTIMAL Randomized Controlled Trial (OPTIMAL)

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.

Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and 24 months (outpatient clinic visit or telephone call) after the index procedure.

Study Overview

• Status: Active, not recruiting
• Conditions: Left Main Coronary Artery Stenosis
• Intervention / Treatment: Device: IVUS guided Percutaneous Coronary Intervention; Device: QCA guided Percutaneous Coronary Intervention

• Study Type: Interventional
• Enrollment (Actual): 807
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ernest Spitzer, MD; Phone Number: 0031102062828; Email: E.Spitzer@ECRI-Trials.com
• Study Contact Backup: Name: Anita van der Wal; Phone Number: 0031102062828

Study Locations

• Italy
  • Bergamo, Italy
    • Asst Papa Giovanni Xxiii
  • Ferrara, Italy
    • A.O.U. di Ferrara
  • Firenze, Italy
    • Interventistica Cardiologica Strutturale
  • Milan, Italy
    • ASST Niguarda
  • Milan, Italy
    • Policlinco San Donato
  • Milan, Italy
    • Sant'Ambrogio Clinical Institute
  • Rome, Italy
    • Policlinico Umberto I
  • Verona, Italy
    • AOUI Verona
• Spain
  • A Coruña, Spain
    • Hospital Universitario de A Coruna
  • Barcelona, Spain
    • Hospital de Bellvitge
  • Barcelona, Spain
    • Hospital Vall d´hebron
  • Córdoba, Spain
    • Hospital Reina Sofía
  • Gijon, Spain
    • Hospital de Cabueñes
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Murcia, Spain
    • Hospital Clinico Universiatrio V. Arrixaca
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro
  • Zaragoza, Spain
    • Hospital Clinico Lozano Blesa
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital
  • Bournemouth, United Kingdom
    • Royal Bournemouth Hospital
  • Brighton, United Kingdom
    • Royal Sussex Country Hospital
  • Bristol, United Kingdom
    • Bristol Royal Infirmary
  • Cardiff, United Kingdom
    • University Hospital of Wales
  • Clydebank, United Kingdom
    • Golden Jubilee National Hospital
  • Leeds, United Kingdom
    • Leeds General Infirmary
  • London, United Kingdom
    • St Bartholomew'S Hospital
  • Newcastle Upon Tyne, United Kingdom
    • The Freeman Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient must be ≥ 18 years of age;
2. De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*.
3. Stable or unstable angina, non-ST segment myocardial infarction, documented silent ischemia or a positive functional study (e.g. by pressure or angiography derived indices).
4. Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.
5. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.
6. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.

Exclusion Criteria:

1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
2. Ongoing MI or recent MI with cardiac biomarker levels still elevated.
3. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.
4. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.
5. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.
6. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration
7. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.
8. Non-cardiac co-morbidities with a life expectancy less than 2 years.
9. Currently participating in another trial and 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 enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
Active Comparator: QCA guided PCI; QCA will be used to determine lesion characteristics	Device: QCA guided Percutaneous Coronary Intervention; QCA will be used to determine lesion characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 and 2 years.	1 and 2 years follow up
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 1 and 2 years.	1 and 2 years follow up
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.	1 year follow up
All individual components of PoCE at all time points.	All individual components of PoCE at all time points.	1 and 2 years follow up
All individual components of DoCE at all time points.	All individual components of DoCE at all time points.	1 and 2 years follow up
Definite and probable stent thrombosis	Definite and probable stent thrombosis according to ARC definition	1 and 2 years
Hospitalization for heart failure	Investigator reported hospitalization for heart failure	2 years

Collaborators and Investigators

• Sponsor: ECRI bv
• Collaborators: Boston Scientific Corporation; Philips Healthcare
• Investigators: Principal Investigator: Adrian Banning, Prof, Oxford University Hospitals NHS Trust; Principal Investigator: Luca Testa, Dr., Policlinco San Donato

Publications and helpful links

General Publications

• 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.

Helpful Links

• Rationale and Design of the OPTIMAL Trial

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PCI; IVUS; Left Main; QCA; Treatment Strategy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: ECRI-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes