Cardiovascular Diseases, Coronary Disease, Coronary Stenosis, Myocardial Ischemia
Conditions
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.
Interventions
COMBINATION_PRODUCTEluNIR Ridaforolimus Eluting Coronary Stent System
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
Sponsors
Medinol Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 3\. An attempt (whether successful or not) was made to implant a 2.25 mm EluNIR stent (Stent was advanced beyond the guiding catheter). 4\. Non-target lesion PCIs are allowed depending on the time interval and conditions as follows: 1. 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. 2. Less than 24 hours prior to Index Procedure: Not allowed (see
Exclusion criteria
#2). c. 24 hours-30 days prior to Index Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the index procedure if successful and uncomplicated as defined above. 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. 5\. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic inclusion criteria (visual estimate): 6\. 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. 7\. 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. 8\. Overlapping stents are allowed as long as at least one of the stents implanted is the EluNIR 2.25 mm diameter stent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | At 30 days | 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. |
| TLF | At 6 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion success | 30 Days, 6 Months & 1Year | Lesion success is defined as achievement of a final in-stent residual diameter stenosis of \<30% (by QCA) using any percutaneous method. |
| Procedure success | 30 Days, 6 Months & 1Year | 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. |
| Target vessel failure | 30 Days, 6 Months & 1 Year | TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR) |
| Major adverse cardiac events | 30 Days, 6 Months & 1Year | MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR |
| All-cause mortality | 30 Days, 6 Months & 1 Year | cardiac death, vascular death, non cardiac death |
| TLF | 6 Months and 1 Year | Target Lesion Failure at 6 months (for all patients enrolled) and 1 year |
| MI | 30 Days, 6 Months & 1Year | 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 |
| Target vessel related MI | 30 Days, 6 Months & 1 Year | Target vessel related MI |
| Ischemia-driven TLR | 30 Days, 6 Months & 1 Year | 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 |
| Ischemia-driven TVR | 30 Days, 6 Months & 1Year | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel). |
| Stent thrombosis | 30 Days, 6Months & 1Year | ARC definite and probable (Circulation 2007;115:2344-51) |
| Cardiac death | 30 Days, 6 Months & 1Year | 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. |
| Device success | 30 Days, 6 Months & 1 Year | 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. |
Countries
Israel
Outcome results
None listed