MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

Inclusion Criteria

• Patient with indication for PCI including angina (stable/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 subacute STEMI. For subacute STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >72 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
• Non-target vessel PCI are allowed prior to enrollment 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 enrollment 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 e.g. cobalt, nickel, chromium, 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 (Drugs that inhibit P2Y12 such as clopidogrel and prasugrel), or heparin, 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 any other investigational drug or device clinical trial that has not reached its primary endpoint, or plans to participate in any clinical trial.
• Women who are pregnant or breastfeeding (women of child-bearing potential, defined as females of childbearing potential if they have not undergone a permanent contraceptive operation or they are not postmenopausal, must have a negative pregnancy test within one week before treatment. Permanent contraceptive operation is defined as: hysterectomy, hysterosalpingectomy, or bilateral oophorectomy. The status of a female should be considered as postmenopausal when she has not had a period for 12 consecutive months without an alternative medical cause).
• 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):

• Target lesions in more than two (2) major coronary arteries (i.e., two of LAD, LCX, RCA) and their respective branches (the Ramus Intermedius is defined as a branch of the LCX).
• More than two target lesions per target vessel are planned (two lesions separated by less than 10 mm that can be covered by a single stent are considered as one lesion).
• More than 100 mm l