SPIRIT PRIME Clinical Trial
Condition: Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Coronary Restenosis; Ischemia
Intervention: Core size Xience Prime; Xience Prime Long Lesion (LL)
Intervention description: Core size includes a range of stent sizes.; Long lesion stent sizes include a range of sizes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug eluting stents; stents; Angioplasty; myocardial ischemia; coronary artery stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Long lesion

Summary:

      To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion
      (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter
      in subjects with symptomatic heart disease due to a maximum of two de novo native coronary
      artery lesions, each in a different epicardial vessel.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be at least 18 years of age.

          2. Subject or a legally authorized representative must provide written informed consent
             prior to any study related procedure, per site requirements.

          3. 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).

          4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG)
             surgery.

          5. Subject must agree to undergo all protocol-required follow-up procedures.

          6. Subject must agree not to participate in any other clinical study for a period of one
             year following the index procedure.

        Angiographic Inclusion Criteria

          1. One or two de novo target lesions each in a different epicardial vessel.

          2. 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.

          3. 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.

          4. 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

          5. 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:

          1. 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.

          2. The subject is currently experiencing clinical symptoms consistent with new onset AMI,
             such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

          3. Subject has current unstable cardiac arrhythmias associated with hemodynamic
             instability.

          4. 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).

          5. Subject has received coronary brachytherapy in any epicardial vessel (target or non
             target).

          6. Subject has received any organ transplant or is on a waiting list for any organ
             transplant.

          7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30
             days prior to or within one year after the index procedure.

          8. Subject is receiving or scheduled to receive planned radiotherapy to the
             chest/mediastinum.

          9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or
             autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus
             etc.).

         10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

         11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.

         12. 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.

         13. Elective surgery is planned within 12 months after the procedure that will require
             discontinuing either aspirin or clopidogrel.

         14. 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).

         15. 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).

         16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
             transfusions.

         17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological
             attack (TIA) within the past six months.

         18. Subject has had a significant gastro-intestinal or significant urinary bleed within
             the past six months.

         19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
             insertion.

         20. 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).

         21. Subject is currently participating in another clinical study that has not yet
             completed its primary endpoint.

         22. 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.

          1. 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.

          2. 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.

          3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.

          4. Another lesion requiring revascularization is located in the same epicardial vessel of
             the target lesion.

          5. Restenotic target lesion.

          6. Aorto-ostial target lesion (within 3 mm of the aorta junction).

          7. Target lesion is in a left main location.

          8. Target lesion located within 2 mm of the origin of the LAD or LCX.

          9. Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or
             within the lesion.

         10. Heavy calcification proximal to or within the target lesion.

         11. Target vessel contains thrombus as indicated in the angiographic images.

         12. 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).

         13. Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty,
             stent, cutting balloon, atherectomy) < 9 months prior to index procedure.

         14. Non-target vessel is previously treated with any type of PCI < 90 days prior to the
             index procedure.

         15. 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.