Clinical trial NCT04111770: The OPTIMAL Randomized Controlled Trial
Official title: OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Left Main Coronary Artery Stenosis
Keywords: IVUS
PCI
Left Main
QCA
Treatment Strategy
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare
name: Boston Scientific Corporation
First posted: 2019-10-01
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient-oriented Composite Endpoint (POCE)
timeFrame: 2 years follow up
Secondary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1 and 2 years follow up
measure: Vessel-oriented Composite Endpoint (VoCE)
timeFrame: 1 and 2 years follow up
measure: Patient-oriented Composite Endpoint (POCE)
timeFrame: 1 year follow up
measure: All individual components of PoCE at all time points.
timeFrame: 1 and 2 years follow up
measure: All individual components of DoCE at all time points.
timeFrame: 1 and 2 years follow up
measure: Definite and probable stent thrombosis
timeFrame: 1 and 2 years
measure: Hospitalization for heart failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Ferrara
country: Italy
facility: A.O.U. di Ferrara
city: Firenze
country: Italy
facility: Interventistica Cardiologica Strutturale
city: Milan
country: Italy
facility: ASST Niguarda
city: Milan
country: Italy
facility: Policlinco San Donato
city: Milan
country: Italy
facility: Sant'Ambrogio Clinical Institute
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Verona
country: Italy
facility: AOUI Verona
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Gijon
country: Spain
facility: Hospital de Cabueñes
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital Clinico Universiatrio V. Arrixaca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex Country Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal infirmary
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Adrian Banning, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinco San Donato
name: Luca Testa, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.