An observational study in Coronary Artery Disease, sponsored by Saint Luke's Health System. Completed at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by Saint Luke's Health System · Observational
The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort design to follow patients who have multivessel or left main coronary artery disease ("surgical anatomy" according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be selected to participate in the registry from a national network of leading centers across the United States with recognized expertise in both complex PCI and coronary artery bypass surgery. We will invite leading cardiac centers, as defined by US News and World reports rankings for heart care. Additional sites may be added to meet the target enrollment goal.
Objectives 1. Compare 30-day mortality and the composite of mortality and morbidity following high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons (STS) survival and morbidity in patients with severe multivessel or left main coronary artery disease (CAD).
2. Compare the 12-month health status and clinical outcomes of surgically ineligible multivessel or left main CAD patients treated with PCI compared to those treated with a medical therapy alone.
3. Understand the association between completeness of revascularization and long-term health status and clinical outcomes among patients with multivessel or left main CAD treated with PCI deemed ineligible for surgery.
4. Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival (ASCERT risk model)
5. Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease (CAD).
6. Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD.
7. Describe the frequency and predictors of complete revascularization in this population.
8. Describe the costs and costs per quality adjusted life year (QALY) gained of the strategy of management of multivessel or left main CAD with PCI versus medical therapy among surgically ineligible patients.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 750 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients identified as having Coronary Artery Disease with Left Main or multivessel involvement, who have been deemed ineligible to receive coronary bypass surgery as treatment.
Inclusion Criteria:
- Participant Selection Inclusion Criteria
Exclusion Criteria:
Exclusion Criteria
Patients who have an initial treatment strategy of using guideline-directed medical therapy only.
Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy.
30 day survival following high risk percutaneous coronary revascularization who are at high risk.
Patients will be followed with phone calls at 30 days.
Time frame: 30 days
12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.
Patients will be called at 12 months time by the centralized follow up center.
Time frame: 12 months
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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