Stenosis Clinical Trial
Official title:
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent -
BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent
System is a single use device/drug combination product comprising:
- A mounted Cobalt Chromium (CoCr) alloy based stent
- A Rapid Exchange (RX) delivery system
- A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®
- Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving
coronary luminal diameter in patients with symptomatic heart disease due to lesions in
vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.
This is a prospective, multi-center, single arm, open label, clinical trial. Lesions planned
to be treated must be declared and recorded at time of enrollment. Planned staged procedures,
if necessary, must be declared immediately post procedure. Clinical follow-up will be
performed at 30 days.
Telephone follow-ups will be performed at 6 months and 1 year post procedure.
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