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

NCT04761939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2024-11-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoram Richter, PhD · Sponsor GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-11-02
Completion
2022-02-20

Countries

  • Israel

Study Locations

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Entities

Diseases

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 NCT04761939 on ClinicalTrials.gov