The OPTIMAL Randomized Controlled Trial

Overview

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.

Full Title of Study: “OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

Interventions

  • Device: 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.
  • Device: QCA guided Percutaneous Coronary Intervention
    • QCA will be used to determine lesion characteristics

Arms, Groups and Cohorts

  • Experimental: IVUS guided PCI
    • Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
  • Active Comparator: QCA guided PCI
    • QCA will be used to determine lesion characteristics

Clinical Trial Outcome Measures

Primary Measures

  • Patient-oriented Composite Endpoint (POCE)
    • Time Frame: 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 Measures

  • Device-oriented Composite Endpoint (DoCE)
    • Time Frame: 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.
  • Vessel-oriented Composite Endpoint (VoCE)
    • Time Frame: 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.
  • Patient-oriented Composite Endpoint (POCE)
    • Time Frame: 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.
    • Time Frame: 1 and 2 years follow up
    • All individual components of PoCE at all time points.
  • All individual components of DoCE at all time points.
    • Time Frame: 1 and 2 years follow up
    • All individual components of DoCE at all time points.
  • Definite and probable stent thrombosis
    • Time Frame: 1 and 2 years
    • Definite and probable stent thrombosis according to ARC definition
  • Hospitalization for heart failure
    • Time Frame: 2 years
    • Investigator reported hospitalization for heart failure

Participating in This Clinical Trial

Inclusion Criteria

1. The patient must be ≥ 18 years of age;

2. De novo lesion of the LM (ostial, shaft or distal) where PCI is considered appropriate and feasible by the Heart Team*.

3. 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).

4. Any left-main Medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included.

5. A patient with a previous coronary artery bypass graft (CABG) with no patent bypass on the LCA may be included.

6. Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.

Exclusion Criteria

1. 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).

2. Ongoing MI or recent MI with cardiac biomarker levels still elevated.

3. Previous history of CABG with patent Left Internal Mammary Artery (LIMA) to LAD and/or patent graft to the left circumflex coronary.

4. Prior PCI of the left-main or the ostium of the LAD or the ostium of the LCX at any time prior to enrolment.

5. Prior PCI in LCA (e.g. mid LAD) within the previous 30 days.

6. Known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (DAPT) duration

7. Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization.

8. Non-cardiac co-morbidities with a life expectancy less than 2 years.

9. 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ECRI bv
  • Collaborator
    • Philips Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adrian Banning, Prof, Principal Investigator, Oxford University Hospitals NHS Trust
    • Luca Testa, Dr., Principal Investigator, Policlinco San Donato
  • Overall Contact(s)
    • Ron van Amsterdam, PhD, DipPharMed, +31 (0)10 206 28 00, rvamsterdam@cardialysis.nl

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