Outcomes of Surgically Ineligible Patients With Multivessel CAD

NCT02996877 | Completed

• 1 other identifier: ISROTH10299
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

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.

  30 days

Secondary Outcomes (1)

• 12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only.

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Piedmont Heart Institute, Inc., Atlanta, GA: collaborator

Study Sites (21)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Unifersity of California San Diego Medical Center

San Diego, California, 92037, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30606, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Northwell Health System

Manhasset, New York, 11030, United States

Location

Columiba University Medical Center

New York, New York, 10032, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Adam C Salisbury, MD MSc

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

• David E Kandzari, MD

  Piedmont Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

• James A Grantham, MD

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: December 15, 2016
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (21)