Status:
ACTIVE_NOT_RECRUITING
The OPTIMAL Randomized Controlled Trial
Lead Sponsor:
ECRI bv
Collaborating Sponsors:
Philips Healthcare
Boston Scientific Corporation
Conditions:
Left Main Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 qualit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT04111770
Start Date
July 8 2020
End Date
July 1 2025
Last Update
February 20 2024
Active Locations (28)
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1
ASST Papa Giovanni XXIII
Bergamo, Italy
2
A.O.U. di Ferrara
Ferrara, Italy
3
Interventistica Cardiologica Strutturale
Florence, Italy
4
ASST Niguarda
Milan, Italy