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

Medinol Ltd.1 site in 1 country58 target enrollmentSeptember 2016

ConditionsStenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stenosis
Sponsor: Medinol Ltd.
Enrollment: 58
Locations: 1
Primary Endpoint: Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

December 16, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medinol Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with an indication for PCI including 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, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
•Non-target vessel PCI are allowed prior to enrollment depending on the time interval and conditions as follows:
•During Baseline Procedure:
•PCI of non-target vessels performed during the baseline procedure itself immediately prior to enrollment if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.
•Less than 24 hours prior to Baseline Procedure:
•Not allowed (see exclusion criteria #2). 24 hours-30 days prior to Baseline Procedure: PCI of non-target vessels 24 hours to 30 days prior to enrollment if successful and uncomplicated as defined above.
•In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI.
•If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
•Over 30 days prior to Baseline Procedure:
•a. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated.

Exclusion Criteria

•General Exclusion Criteria:
•STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
•PCI within the 24 hours preceding the baseline procedure.
•Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.
•History of stent thrombosis.
•Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
•Subject is intubated.
•Known LVEF \<30%.
•Relative or absolute contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
•Calculated creatinine clearance \<30 mL/min using Cockcroft-Gault equation (\<40 mL/min for subjects participating in the angiographic follow-up sub-study).