Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

Inclusion Criteria

• Patient with indication for PCI including angina/silent ischemia/NSTEMI/recent STEMI
• Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions
• Patient/legal guardian willing & able to provide informed written consent & comply with follow-up visits & testing schedule
• Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm.
• Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft

Exclusion Criteria

• STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked
• PCI within 24 hours preceding baseline procedure
• Non-target lesion PCI in target vessel within 12 months of baseline procedure
• History of stent thrombosis
• Cardiogenic shock (persistent hypotension [systolic blood pressure 700,000 cells/mm3
• White blood cell (WBC) count <3, 000 cells/mm3
• Clinically significant liver disease
• Active peptic ulcer/active bleeding from any site
• Bleeding from any site within prior 8 wks requiring active medical/surgical attention
• If femoral access is planned, significant peripheral arterial disease that precludes safe insertion of 6F sheath
• History of bleeding diathesis/coagulopathy/will refuse blood transfusions
• Cerebrovascular accident/transient ischemic attack within past 6 months, or any permanent neurologic defect attributed to CVA
• Known allergy to study stent components, BioNIR or Resolute
• Known allergy to protocol-required concomitant medications: aspirin/DAPT (clopidogrel, prasugrel, ticagrelor)/heparin and bivalirudin/iodinated contrast that cannot be adequately pre-medicated
• Any co-morbid condition that may cause non-compliance with protocol (e.g. dementia, substance abuse) /reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease)
• Patient participating/plans to participate in another investigational drug/device clinical trial that has not reached its primary endpoint
• Pregnant/breastfeeding women (women of child-bearing potential must have a negative pregnancy test within 1 wk before treatment)
• Women who intend to become pregnant within 12 months after baseline procedure (sexually active women of child-bearing potential must agree to use a reliable method of contraception from time of screening through 12 months post baseline procedure)
• Patient has received/is on a waiting list for an organ transplant
• Patient receiving/scheduled to receive chemotherapy within 30 days before/any time after the baseline procedure
• Patient receiving oral/intravenous immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease (e.g. HIV); corticosteroids are allowed
• More than 100mm length of planned stenting in the entire coronary tree
• Unprotected left main lesions ≥30%, or planned left main intervention
• Ostial LAD/LCX lesions (stenting of any diseased segment within 5mm of the unprotected left main coronary artery)
• Bifurcation lesions with planned dual stent implantation
• Stenting of lesions due to DES restenosis
• Another lesion in a target/non-target vessel (including all side branches) is present that requires/has high probability of requiring PCI within 12 months after baseline procedure