Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
806 participants
INTERVENTIONAL
2020-07-08
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IVUS guided PCI
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
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.
Angiography-guided PCI
Qualitative or quantitative angiography will be used to determine lesion characteristics
Qualitative or quantitative angiography will guide percutaneous coronary intervention
Qualitative or quantitative angiography will be used to determine lesion characteristics
Interventions
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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.
Qualitative or quantitative angiography will guide percutaneous coronary intervention
Qualitative or quantitative angiography will be used to determine lesion characteristics
Eligibility Criteria
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Inclusion Criteria
2. De novo lesion in an unprotected left main coronary artery (ULMCA; ostial, shaft or distal) OR ostial left anterior descending artery (LAD) or ostial circumflex (LCX), both compatible with one Medina class of LM disease; or ostial intermediate branch disease;
3. PCI is considered appropriate and feasible by the treating interventionalist;
4. Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI;
5. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.
Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included.
Exclusion Criteria
2. Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
3. IVUS is strictly required for pre-PCI lesion severity assessment
4. ST-elevation myocardial infarction, cardiogenic shock;
5. Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX;
6. Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment;
7. Prior PCI of any other (i.e. non-LM, non-ostial-LAD and non-ostial-LCX) coronary artery lesions within 30 days prior to enrollment;
8. Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
9. Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
10. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment;
11. Non-cardiac co-morbidities with a life expectancy less than 2 years;
12. Currently participating in another trial that is 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 enrollment.
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Cardialysis B.V.
INDUSTRY
ECRI bv
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Banning, Prof
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
Luca Testa, Dr.
Role: PRINCIPAL_INVESTIGATOR
Policlinco San Donato
Locations
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ASST Papa Giovanni XXIII
Bergamo, , Italy
A.O.U. di Ferrara
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
Countries
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References
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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.
Related Links
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Rationale and Design of the OPTIMAL Trial
Other Identifiers
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ECRI-013
Identifier Type: -
Identifier Source: org_study_id
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