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.
Study Type
OBSERVATIONAL
Enrollment
81
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
Soroka Medical Center
Beersheba, Israel
Hillel Yafe Medical Center
Hadera, Israel
Rambam Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Sourasky Medical Center
Tel Aviv, Israel
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.
Time frame: 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.
Time frame: At 6 month
TLF
Target Lesion Failure at 6 months (for all patients enrolled) and 1 year
Time frame: 6 Months and 1 Year
Device success
Device success is defined as achievement of a final in-stent residual diameter stenosis of \<30% (by QCA), using the EluNIR 2.25 mm stent only and without a device malfunction.
Time frame: 30 Days, 6 Months & 1 Year
Lesion success
Lesion success is defined as achievement of a final in-stent residual diameter stenosis of \<30% (by QCA) using any percutaneous method.
Time frame: 30 Days, 6 Months & 1Year
Procedure success
Procedure success is defined as achievement of a final in-stent diameter stenosis of \<30% (by QCA) using the assigned device and/or with any adjunctive devices, without the occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay.
Time frame: 30 Days, 6 Months & 1Year
Target vessel failure
TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
Time frame: 30 Days, 6 Months & 1 Year
Major adverse cardiac events
MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR
Time frame: 30 Days, 6 Months & 1Year
All-cause mortality
cardiac death, vascular death, non cardiac death
Time frame: 30 Days, 6 Months & 1 Year
Cardiac death
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 30 Days, 6 Months & 1Year
MI
Post-PCI (Type 4a) and post-CABG (Periprocedural) MIs (Type 5), Periprocedural MIs will be defined based on the SCAI definitions and Spontaneous MI (MI Type I) will be defined based on the Universal Definition of Myocardial Infarction
Time frame: 30 Days, 6 Months & 1Year
Target vessel related MI
Target vessel related MI
Time frame: 30 Days, 6 Months & 1 Year
Ischemia-driven TLR
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Time frame: 30 Days, 6 Months & 1 Year
Ischemia-driven TVR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel).
Time frame: 30 Days, 6 Months & 1Year
Stent thrombosis
ARC definite and probable (Circulation 2007;115:2344-51)
Time frame: 30 Days, 6Months & 1Year
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