NCT02834806

BIONICS Israel Trial

BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, single arm, open label, clinical trial. Lesions planned to be treated must be declared and recorded at time of enrollment. Planned staged procedures, if necessary, must be declared immediately post procedure. Clinical follow-up will be performed at 30 days. Telephone follow-ups will be performed at 6 months and 1 year post procedure.

Conditions

• Stenosis

Interventions

Type	Name	Description
DEVICE	BioNIR Ridaforolimus Eluting Coronary Stent System	BioNIR Ridaforolimus eluting coronary stent system with modified delivery system

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-01-16
• Completion: 2017-12-16
• First posted: 2016-07-15
• Last updated: 2020-09-24
• Results posted: 2020-09-24

Locations

1 site across 1 country: Israel