The OPTIMAL Randomized Controlled Trial
- Conditions
- Left Main Coronary Artery Stenosis
- Interventions
- Device: IVUS guided Percutaneous Coronary InterventionDevice: QCA guided Percutaneous Coronary Intervention
- Registration Number
- NCT04111770
- Lead Sponsor
- ECRI bv
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 807
- The patient must be ≥ 18 years of age;
- De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*.
- 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).
- Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.
- A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.
- Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.
- 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).
- Ongoing MI or recent MI with cardiac biomarker levels still elevated.
- Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.
- Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.
- Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.
- Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration
- Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.
- Non-cardiac co-morbidities with a life expectancy less than 2 years.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVUS guided PCI 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 PCI QCA guided Percutaneous Coronary Intervention QCA will be used to determine lesion characteristics
- Primary Outcome Measures
Name Time Method Patient-oriented Composite Endpoint (POCE) 2 years follow up 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.
- Secondary Outcome Measures
Name Time Method Vessel-oriented Composite Endpoint (VoCE) 1 and 2 years follow up 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.
Device-oriented Composite Endpoint (DoCE) 1 and 2 years follow up 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.
Definite and probable stent thrombosis 1 and 2 years Definite and probable stent thrombosis according to ARC definition
Hospitalization for heart failure 2 years Investigator reported hospitalization for heart failure
Patient-oriented Composite Endpoint (POCE) 1 year follow up 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.
All individual components of PoCE at all time points. 1 and 2 years follow up All individual components of PoCE at all time points.
All individual components of DoCE at all time points. 1 and 2 years follow up All individual components of DoCE at all time points.
Trial Locations
- Locations (28)
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
AOUI Verona
🇮🇹Verona, Italy
Hospital Universitario de A Coruña
🇪🇸A Coruña, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Clinico Universiatrio V. Arrixaca
🇪🇸Murcia, Spain
Hospital Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Hospital de Cabueñes
🇪🇸Gijon, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Clinico Lozano Blesa
🇪🇸Zaragoza, Spain
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Bristol Royal infirmary
🇬🇧Bristol, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Royal Sussex Country Hospital
🇬🇧Brighton, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
The Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Policlinico Umberto I
🇮🇹Rome, Italy
Sant'Ambrogio Clinical Institute
🇮🇹Milan, Italy