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

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: 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.