BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial

NCT03702608 | Completed Results FDA Device

• 1 other identifier: EluNIR-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Stenosis

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint: Device Success

  Device success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only and without a device malfunction.

  30 day

• Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events)

  No 30 day MACE: MACE (Major Adverse Cardiac Events) is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.

  30 Day

Study Arms (1)

EluNIR 38mm

OTHER

Combination Product: EluNIR Ridaforolimus Eluting Coronary Stent System

Interventions

EluNIR Ridaforolimus Eluting Coronary Stent System COMBINATION_PRODUCT

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

EluNIR 38mm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• 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.
• An attempt (whether successful or not) was made to implant a 38 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
• Non-target vessel PCI are allowed prior to the screening for eligibility 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 screening for eligibility, 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:

• ii. 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 have been drawn at least 6 and 12 hours after the non-target vessel PCI.
• iii. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
• d. Over 30 days prior to Baseline Procedure: PCI of non-target vessels performed greater than 30 days prior to baseline 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 ≥2.75 mm to ≤4.25 mm.
• Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus, CTO, bifurcation lesions, ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
• Overlapping stents are allowed as long as the first stent implanted is the EluNIR 38 mm long stent
• 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)

Medinol LTD

Tel Aviv, Israel

Location

Related Publications (1)

• Jonas M, Ben-Yehuda O, Banai S, Segev A, Danenberg H, Assali A, Tuvali O, Haberman D, Chernin G. Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38 mm prospective trial. Coron Artery Dis. 2023 Sep 1;34(6):410-414. doi: 10.1097/MCA.0000000000001264. Epub 2023 Jul 4.

  PMID: 37471280 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

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

dinak@medinol.com

+97237679032

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: October 11, 2018
• Study Start: November 14, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 30, 2020
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-05

Locations

IL (1)