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CompletedNCT02996877OPTIMUMUpdated Oct 24, 2025

Outcomes of Surgically Ineligible Patients With Multivessel CAD

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

Inclusion Criteria:

- Participant Selection Inclusion Criteria

  1. Participant undergoes coronary angiography revealing unprotected left main stenosis of > 50%, 3 vessel disease with stenoses > 70% or 2 vessel coronary disease (>70%) with one lesion involving the proximal LAD. Patients will also be included if there is FFR evidence of flow limiting stenosis (FFR ≤ 0.80) in the setting of > 40% angiographic stenosis the left main, 3 epicardial coronaries or 2 vessels including the proximal LAD. Patients with prior bypass surgery will be included if they have ≥ 2 epicardial vascular distributions subtended by a severe native coronary stenosis with either no bypass graft supplying the vessel, a severely diseased (>70% stenosis) bypass graft supplying the affected vessel or an occluded bypass graft to the affected vessel.
  2. Patient considered high risk for coronary artery bypass surgery and declared ineligible for surgery by the heart team.
  3. Patient is experiencing clinical symptoms consistent with obstructive coronary artery disease or with evidence of coronary ischemia on non-invasive/invasive (FFR) functional testing.
  4. Subject is ≥ 18 years of age at the time of consent and is willing to sign an informed consent document approved by the enrolling hospital's Institutional Review Board and follow-up for 12-months following enrollment in the study
  5. Patient is able to speak English.

Exclusion Criteria:

  • Exclusion Criteria

    1. Established iodine allergy that cannot be managed medically, allergy to everolimus, or absolute contraindication to aspirin, P2Y12 antagonist therapy with either clopidogrel, prasgurel, ticagrelor or ticlopidine or absolute contraindication to bivalirudin and heparin precluding procedural anticoagulation.
    2. Emergent revascularization required for ST-elevation myocardial infarction or cardiac arrest, or severe sustained hemodynamic instability.
    3. Patients presenting late after STEMI (> 12 hours after symptom onset) for "salvage" PCI.
    4. Too hard of hearing to do follow-up by telephone.
    5. Currently incarcerated.
    6. Dementia.
    7. Subjects with no way to be contacted by telephone for follow-up, including those who live outside of the U.S. or spend significant time outside of the U.S.
    8. Patients with conditions such as cancer, mental illness, or other pathology which, in the opinion of the local investigator, might put the patient at risk, preclude follow-up or confound the results of the study.
    9. Patients who refuse.
    10. Female subjects with a positive quantitative or qualitative pregnancy test will not be enrolled.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Guideline Directed Medical Therapy

    Patients who have an initial treatment strategy of using guideline-directed medical therapy only.

  • Percutaneous Coronary Intervention

    Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

21 sites
  • Banner University Medical Center
    Phoenix, Arizona 85006, United States
  • Unifersity of California San Diego Medical Center
    San Diego, California 92037, United States
  • Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Piedmont Heart Institute
    Atlanta, Georgia 30606, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Saint Luke's Hospital of Kansas City
    Kansas City, Missouri 64111, United States
  • Washington University in Saint Louis
    St Louis, Missouri 63110, United States
  • Northwell Health System
    Manhasset, New York 11030, United States
  • Columiba University Medical Center
    New York, New York 10032, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Geisinger Health System
    Danville, Pennsylvania 17822, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • University of Virginia Medical Center
    Charlottesville, Virginia 22908, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • Charleston Area Medical Center
    Charleston, West Virginia 25304, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02996877
Lead sponsor
Saint Luke's Health System
Collaborators
Piedmont Heart Institute, Inc., Atlanta, GA
Responsible party
Sponsor
First posted
Dec 19, 2016
Start date
Dec 15, 2016
Primary completion
Jun 22, 2020
Completion
Jun 22, 2020
Last update
Oct 24, 2025

Study contacts

Adam C Salisbury, MD MSc
principal investigator · Saint Luke's Health System
David E Kandzari, MD
principal investigator · Piedmont Heart and Vascular Institute
James A Grantham, MD
principal investigator · Saint Luke's Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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