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

Launched by REVA MEDICAL, INC. · Sep 1, 2015

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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