BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial

NCT04761939 | Completed

• 1 other identifier: EluNIR-005
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 9

Brief Summary

Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR. Subject Population: Subjects who underwent PCI for 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, and recent STEMI (\>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent. Trial Design and Methods: This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.

Conditions

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• MACE

  Combined early efficacy and safety endpoint: MACE at 30 days for all patients enrolled. MACE is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.

  At 30 days

• TLF

  Combined late efficacy and safety endpoint: Target Lesion Failure (TLF) at 6 months (evaluated for the first 50% of patients enrolled) Defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

  At 6 month

Secondary Outcomes (13)

• TLF

  6 Months and 1 Year

• Device success

  30 Days, 6 Months & 1 Year

• Lesion success

  30 Days, 6 Months & 1Year

• Procedure success

  30 Days, 6 Months & 1Year

• Target vessel failure

  30 Days, 6 Months & 1 Year

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 pre-mounted Cobalt Chromium (CoCr) alloy based stent - 2.25 mm Diameter and 8mm, 12mm, 15mm, 17mm, 20mm, 24mm, 28mm and 33mm length * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0

Eligibility Criteria

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

Study Population

Subjects who underwent PCI for 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, and recent STEMI (\>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.

You may qualify if:

• Age ≥ 18 years. 2. 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 2.25 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
• \. Non-target lesion PCIs are allowed depending on the time interval and conditions as follows:
• During Index Procedure:
• 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 Index Procedure:

You may not qualify if:

• ii. In addition, in cases where non-target vessel PCI has occurred 24-72 hours prior to the index 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 Index Procedure: PCI of non-target lesions performed greater than 30 days prior to index 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 ≥2.25 mm to ≤2.5 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 at least one of the stents implanted is the EluNIR 2.25 mm diameter 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 index procedure.
• Non-target lesion PCI in the target vessel 24 hours to 30 days.
• Planned staged procedures.
• Brachytherapy in conjunction with the index 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.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (9)

Soroka Medical Center

Beersheba, Israel

Location

Hillel Yafe Medical Center

Hadera, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases

Study Officials

• Yoram Richter, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: February 21, 2021
• Study Start: December 31, 2020
• Primary Completion: November 2, 2021
• Study Completion: February 20, 2022
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

IL (9)