Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
| Cardialysis B.V. | INDUSTRY |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS guided PCI | Experimental | Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent. |
|
| Angiography-guided PCI | Active Comparator | Qualitative or quantitative angiography will be used to determine lesion characteristics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS guided Percutaneous Coronary Intervention | Device | Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent. |
| 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 longest follow-up. | 2-5 years follow up |
| 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 longest follow-up | 2-5 years follow up |
| Vessel-oriented Composite Endpoint (VoCE) |
Not provided
Inclusion Criteria:
Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian Banning, Prof | Oxford University Hospitals NHS Trust | Principal Investigator |
| Luca Testa, Dr. | Policlinco San Donato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Papa Giovanni XXIII | Bergamo | Italy | ||||
| A.O.U. di Ferrara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41911017 | Result | 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 Jun 11;394(22):2189-2199. doi: 10.1056/NEJMoa2600440. Epub 2026 Mar 30. | |
| 34995276 |
| Label | URL |
|---|---|
| Rationale and Design of the OPTIMAL Trial | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Qualitative or quantitative angiography will guide percutaneous coronary intervention | Device | Qualitative or quantitative angiography will be used to determine lesion characteristics |
|
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 longest follow-up. |
| 2-5 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. | 2 year follow up |
| All individual components of PoCE at all time points. | All individual components of PoCE at all time points. | 2-5 years follow-up |
| All individual components of DoCE at all time points. | All individual components of DoCE at all time points. | 2-5 years follow-up |
| Definite and probable stent thrombosis | Definite and probable stent thrombosis according to ARC definition | 2-5 years follow-up |
| Hospitalization for heart failure | Investigator reported hospitalization for heart failure | 2-5 years follow-up |
| Ferrara |
| Italy |
| Interventistica Cardiologica Strutturale | Florence | Italy |
| ASST Niguarda | Milan | Italy |
| Policlinco San Donato | Milan | Italy |
| Sant'Ambrogio Clinical Institute | Milan | Italy |
| Policlinico Umberto I | Rome | Italy |
| AOUI Verona | Verona | Italy |
| 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 | Gijón | 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 | Spain |
| 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 | United Kingdom |
| Result |
| 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. |