Last updated on May 2018

Outcomes of Surgically Ineligible Patients With Multivessel CAD

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary Artery Disease With Multilvessel or Left Main Involvement | Coronary Artery Disease | Coronary heart disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.