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New registry follows 750 heart patients too sick for bypass

NCT ID NCT02996877

Knowledge-focused Sponsor: Saint Luke's Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 750 people with severe coronary artery disease who were not eligible for bypass surgery. Researchers tracked survival at 30 days and quality of life at 12 months after less invasive procedures or medical therapy alone. The goal was to understand real-world outcomes for this high-risk group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

750 people

The number who actually took part.

Started

Dec 2016

Finished

Jun 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Banner University Medical Center

    Phoenix, Arizona, 85006, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columiba University Medical Center

    New York, New York, 10032, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Geisinger Health System

    Danville, Pennsylvania, 17822, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Northwell Health System

    Manhasset, New York, 11030, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30606, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Unifersity of California San Diego Medical Center

    San Diego, California, 92037, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, 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

  • Washington Hospital Center

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

  • Washington University in Saint Louis

    St Louis, Missouri, 63110, United States

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