The OPTIMAL Randomized Controlled Trial

Left Main Coronary Artery Stenosis Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04111770
• Other study ID #: ECRI-013
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 807
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis
• Left Main Coronary Artery Stenosis

Intervention

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.
• QCA guided Percutaneous Coronary Intervention
QCA will be used to determine lesion characteristics

Locations

Country	Name	City	State
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	A.O.U. di Ferrara	Ferrara
Italy	Interventistica Cardiologica Strutturale	Firenze
Italy	ASST Niguarda	Milan
Italy	Policlinco San Donato	Milan
Italy	Sant'Ambrogio Clinical Institute	Milan
Italy	Policlinico Umberto I	Rome
Italy	AOUI Verona	Verona
Spain	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	Gijon
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
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	Boston Scientific Corporation, Philips Healthcare

Countries where clinical trial is conducted

Italy,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	All individual components of PoCE at all time points.	All individual components of PoCE at all time points.	1 and 2 years follow up
Secondary	All individual components of DoCE at all time points.	All individual components of DoCE at all time points.	1 and 2 years follow up
Secondary	Definite and probable stent thrombosis	Definite and probable stent thrombosis according to ARC definition	1 and 2 years
Secondary	Hospitalization for heart failure	Investigator reported hospitalization for heart failure	2 years

External Links

•   Rationale and Design of the OPTIMAL Trial