BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial

CompletedOBSERVATIONAL
Enrollment

81

Participants

Timeline

Start Date

December 31, 2020

Primary Completion Date

November 2, 2021

Study Completion Date

February 20, 2022

Conditions
Coronary StenosisCoronary DiseaseMyocardial IschemiaCardiovascular Diseases
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 pre-mounted Cobalt Chromium (CoCr) alloy based stent - 2.25 mm Diameter and 8mm, 12mm, 15mm, 17mm, 20mm, 24mm, 28mm and 33mm length~* Delivery System - Rapid Exchange (RX) Coronary System~* Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~* Ridaforolimus drug - CAS Registry Number: 572924-54-0"

Trial Locations (9)

Unknown

Soroka Medical Center, Beersheba

Hillel Yafe Medical Center, Hadera

Rambam Medical Center, Haifa

Wolfson Medical Center, Holon

Meir Medical Center, Kfar Saba

Rabin Medical Center, Petah Tikva

Sheba Medical Center, Ramat Gan

Kaplan Medical Center, Rehovot

Sourasky Medical Center, Tel Aviv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medinol Ltd.

INDUSTRY

NCT04761939 - BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial | Biotech Hunter | Biotech Hunter