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BIONICS - Pharmacokinetics (PK) Trial

NCT02736344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-04-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

BioNIR Ridaforolimus Eluting Coronary Stent

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • David Rizik, MD · Scottsdale Heart Group

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736344 on ClinicalTrials.gov