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BIONICS Israel Trial

NCT02834806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-09-24

Study results available
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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.

Conditions

  • Stenosis

Interventions

DEVICE

BioNIR Ridaforolimus Eluting Coronary Stent System

BioNIR Ridaforolimus eluting coronary stent system with modified delivery system

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • Abid Assali, Prof. MD · Rabin Medical Center

  • Shmuel Banai, Prof. MD · Souraski Medical Center

  • Michael Jonas, MD · Kaplan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-01-16
Completion
2017-12-16

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 NCT02834806 on ClinicalTrials.gov