SPIRIT PRIME Clinical Trial

Inclusion criteria

• Subject must be at least 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must agree to undergo all protocol-required follow-up procedures.
• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

• One or two de novo target lesions each in a different epicardial vessel.
• If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.

• The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
• Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:

• ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
• ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS
• Target lesion(s) must be located in a native coronary artery with length by visual estimation of:

• ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
• > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion criteria

• Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
• The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
• Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
• Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
• Subject has received any organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
• Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
• Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
• Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
• Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
• Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
• Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
• Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
• Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

• Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
• Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
• Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
• Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
• Restenotic target lesion.
• Aorto-ostial target lesion (within 3 mm of the aorta junction).
• Target lesion is in a left main location.
• Target lesion located within 2 mm of the origin of the LAD or LCX.
• Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
• Heavy calcification proximal to or within the target lesion.
• Target vessel contains thrombus as indicated in the angiographic images.
• Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
• Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
• Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
• Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.