BIONICS Israel Trial

NCT02834806 | Completed Results DMC

• 1 other identifier: BioNIR-003
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis

Outcome Measures

Primary Outcomes (1)

• Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory

  during baseline procedure

Secondary Outcomes (2)

• Target Lesion Success

  during baseline procedure

• Procedure Success

  during baseline procedure

Other Outcomes (3)

• Major Adverse Cardiac Events (MACE)

  Clinical follow-up will be performed at 30 days.

• Major Adverse Cardiac Events (MACE)

  Telephone follow up will be performed at 6 months post procedure

• Major Adverse Cardiac Events (MACE)

  Telephone follow up will be performed at 1 year post procedure

Study Arms (1)

BioNIR drug eluting stent system

EXPERIMENTAL

BioNIR Ridaforolimus eluting coronary stent system with modified delivery system

Device: BioNIR Ridaforolimus Eluting Coronary Stent System

Interventions

BioNIR Ridaforolimus Eluting Coronary Stent System DEVICE

BioNIR Ridaforolimus eluting coronary stent system with modified delivery system

BioNIR drug eluting stent system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
• Target lesion(s) must be located in a native coronary artery or bypass graft conduit with visually estimated diameter of ≥2.5 mm to ≤4.25 mm.
• Overlapping stents are allowed.
• 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).

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dina Kofler, VP Clinical Affairs
• Organization: Medinol

dinak@medinol.com

+97237679032

Study Officials

• Abid Assali, Prof. MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

• Shmuel Banai, Prof. MD

  Souraski Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Jonas, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 15, 2016
• Study Start: September 1, 2016
• Primary Completion: January 16, 2017
• Study Completion: December 16, 2017
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)