CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
EluNIR Ridaforolimus Eluting Coronary Stent Systemcombination
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.

Search/NCT03702608
NCT03702608N/ACompleted
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Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR

Medinol Ltd.·interventional·Posted Oct 11, 2018·Updated Oct 28, 2020

In Brief

A clinical study evaluating EluNIR Ridaforolimus Eluting Coronary Stent System for Coronary Stenosis. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Stenosis
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartNov 14, 2018
Primary CompletionMar 1, 2019
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.7 years ago

Interventions

EluNIR Ridaforolimus Eluting Coronary Stent Systemcombination

The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - (PBMA) and CarboSil® * Ridaforolimus drug