The OPTIMAL Randomized Controlled Trial (OPTIMAL)

  • STATUS
    Recruiting
  • End date
    Jul 11, 2025
  • participants needed
    800
  • sponsor
    ECRI bv
Updated on 11 August 2022

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.

Details
Condition Left Main Coronary Artery Stenosis
Treatment IVUS guided Percutaneous Coronary Intervention, QCA guided Percutaneous Coronary Intervention
Clinical Study IdentifierNCT04111770
SponsorECRI bv
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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