Coronary Artery DiseaseOPTIMUMNCT02996877
Outcomes of Surgically Ineligible Patients With Multivessel CAD
An observational study of Coronary Artery Disease, run by Saint Luke's Health System at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 750 participants
- Where
- 21 sitesUnited States
- Study dates
- 15 Dec 2016to 22 Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participant Selection Inclusion Criteria
- 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.
- Patient considered high risk for coronary artery bypass surgery and declared ineligible for surgery by the heart team.
- Patient is experiencing clinical symptoms consistent with obstructive coronary artery disease or with evidence of coronary ischemia on non-invasive/invasive (FFR) functional testing.
- 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
- Patient is able to speak English.
Who cannot join
- 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.
- Emergent revascularization required for ST-elevation myocardial infarction or cardiac arrest, or severe sustained hemodynamic instability.
- Patients presenting late after STEMI (> 12 hours after symptom onset) for "salvage" PCI.
- Too hard of hearing to do follow-up by telephone.
- Currently incarcerated.
- Dementia.
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- 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.
- 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.
- Patients who refuse.
- Female subjects with a positive quantitative or qualitative pregnancy test will not be enrolled.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30606
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Charleston Area Medical Center
Charleston, West Virginia, 25304
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Geisinger Health System
Danville, Pennsylvania, 17822
Henry Ford Hospital
Detroit, Michigan, 48202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Northwell Health System
Manhasset, New York, 11030
Columiba University Medical Center
New York, New York, 10032
Banner University Medical Center
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Unifersity of California San Diego Medical Center
San Diego, California, 92037
University of Washington Medical Center
Seattle, Washington, 98195
Washington University in Saint Louis
St Louis, Missouri, 63110
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry
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).
- 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.
- 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.
- Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival (ASCERT risk model)
- Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease (CAD).
- Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD.
- Describe the frequency and predictors of complete revascularization in this population.
- 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day survival following high risk percutaneous coronary revascularization who are at high risk.
Patients will be followed with phone calls at 30 days.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start15 Dec 2016
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Piedmont Heart Institute, Inc., Atlanta, GA
- Responsible party
- Sponsor
- Investigators
- Adam C Salisbury, MD MSc, Principal investigator, Saint Luke's Health SystemDavid E Kandzari, MD, Principal investigator, Piedmont Heart and Vascular InstituteJames A Grantham, MD, Principal investigator, Saint Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996877
- Sponsor's protocol ID
- ISROTH10299
- Acronym
- OPTIMUM
- Status last verified
- Oct 2025
- First submitted
- 15 Dec 2016
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease: A Prospective Registry
- ClinicalTrials.gov ID
- NCT02996877
- Acronym / sponsor ID
- OPTIMUM / ISROTH10299
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Piedmont Heart Institute, Inc., Atlanta, GA
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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.
- 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.
- Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival (ASCERT risk model)
- Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease (CAD).
- Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD.
- Describe the frequency and predictors of complete revascularization in this population.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participant Selection Inclusion Criteria
- 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.
- Patient considered high risk for coronary artery bypass surgery and declared ineligible for surgery by the heart team.
- Patient is experiencing clinical symptoms consistent with obstructive coronary artery disease or with evidence of coronary ischemia on non-invasive/invasive (FFR) functional testing.
- 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
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 day survival following high risk percutaneous coronary revascularization who are at high risk.
Time frame: 30 days
Patients will be followed with phone calls at 30 days.
1 secondary outcome
12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Saint Luke's Health System at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day survival following high risk percutaneous coronary revascularization who are at high risk. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.