CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
BioNIR Ridaforolimus Eluting Coronary Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02834806N/ACompleted
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BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial

Medinol Ltd.·interventional·Posted Jul 15, 2016·Updated Sep 24, 2020

In Brief

A clinical study evaluating BioNIR Ridaforolimus Eluting Coronary Stent System for Stenosis. Completed, enrolled 58 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStenosis
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 15, 2016
Enrollment StartSep 1, 2016
Primary CompletionJan 16, 2017
Study CompletionDec 16, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.0 years ago

Interventions

BioNIR Ridaforolimus Eluting Coronary Stent Systemdevice

BioNIR Ridaforolimus eluting coronary stent system with modified delivery system