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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Combination Product: EluNIR Ridaforolimus Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria: 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: Not allowed (see exclusion criteria #2). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the baseline procedure if successful and uncomplicated as defined above. 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. Angiographic inclusion criteria (visual estimate): 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 Exclusion Criteria: General Exclusion Criteria: 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). eGFR <30 mL/min Hemoglobin <10 g/dL. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3. White blood cell (WBC) count <3,000 cells/mm3. Clinically significant liver disease. Active peptic ulcer or active bleeding from any site. Bleeding from any site within the prior 8 weeks requiring active medical or surgical attention. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. Known allergy to the study stent components cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds). Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease). Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint. Women who are pregnant or breastfeeding. Women who intend to become pregnant within 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure). Patient has received an organ transplant or is on a waiting list for an organ transplant. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed. Angiographic Exclusion Criteria (visual estimate): Unprotected left main lesions ≥30%, or planned left main intervention. Bifurcation lesions with planned dual stent implantation. Stenting of lesions due to DES restenosis. Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 12 months after the baseline procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EluNIR 38mm<br> | Combination Product: EluNIR Ridaforolimus Eluting Coronary Stent System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |