BIONICS - Pharmacokinetics (PK) Trial
Completed
Conditions studied: Heart Disease
In brief
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.
Key facts
- Study ID
- NCT02736344
- Run by
- Medinol Ltd.
- People needed
- 12
- Starts
- 2016-04-01
- Expected to finish
- 2021-09-01
- Last updated by the study team
- 2022-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Scottsdale Heart Group — Scottsdale, Arizona, United States
- Cardiac and Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.