Last updated on February 2018

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

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 | Coronary heart disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patient has evidence of myocardial ischemia or a positive functional study
  • Target lesion has a visually estimated stenosis of 50% and <100%
  • Target lesion is located in a native coronary artery with average reference vessel diameter 2.5mm and 3.5mm
  • Lesion length 20 mm by visual estimate (N/A for Cohort C)
  • Baseline TIMI flow 2

Exclusion Criteria:

  • The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
  • Patient has a left ventricular ejection fraction < 40%
  • Patient has unprotected left main coronary disease with 50% stenosis
  • The target vessel is totally occluded (TIMI Flow 0 or 1)
  • Target lesion involves a bifurcation (a lesion with a side branch 1.5 mm in diameter containing a 50% stenosis).
  • Target lesion is located within a bypass graft
  • Target lesion has possible or definite thrombus

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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