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BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial

NCT03702608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-10-28

Study results available
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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.

Conditions

  • Coronary Stenosis

Interventions

COMBINATION_PRODUCT

EluNIR Ridaforolimus Eluting Coronary Stent System

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

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2019-03-01
Completion
2020-04-30
FDA Device
Yes

Countries

  • Israel

Study Locations

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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 NCT03702608 on ClinicalTrials.gov