Clinical Trials Directory

Trials / Completed

CompletedNCT04761939

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

Status
Completed
Phase
—
Study type
Observational
Enrollment
81 (actual)
Sponsor
Medinol Ltd. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR. Subject Population: Subjects who underwent PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, and recent STEMI (\>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent. Trial Design and Methods: This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTEluNIR Ridaforolimus Eluting Coronary Stent SystemThe 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

Timeline

Start date
2020-12-31
Primary completion
2021-11-02
Completion
2022-02-20
First posted
2021-02-21
Last updated
2024-11-21

Locations

9 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT04761939. Inclusion in this directory is not an endorsement.