Trials / Completed
CompletedNCT03702608
BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial
Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Medinol Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - (PBMA) and CarboSil® * Ridaforolimus drug |
Timeline
- Start date
- 2018-11-14
- Primary completion
- 2019-03-01
- Completion
- 2020-04-30
- First posted
- 2018-10-11
- Last updated
- 2020-10-28
- Results posted
- 2020-10-28
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03702608. Inclusion in this directory is not an endorsement.