BIONICS - Pharmacokinetics (PK) Trial - Trial NCT02736344
Access comprehensive clinical trial information for NCT02736344 through Pure Global AI's free database. This phase not specified trial is sponsored by Medinol Ltd. and is currently Completed. The study focuses on Heart Disease. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Medinol Ltd.
Timeline & Enrollment
N/A
Apr 01, 2016
Sep 01, 2021
Primary Outcome
Maximum concentration (Cmax)
Summary
The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug
 combination product comprising:
 
 - Stent - mounted Cobalt Chromium (CoCr) alloy based stent
 
 - Delivery System - Rapid Exchange (RX) Coronary System
 
 - Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating
 (CarboSil®)
 
 - Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The
 product is indicated for improving coronary luminal diameter in patients with
 symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm to
 4.25mm, including complex lesions.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT02736344
Device Trial