This research study is currently not recruiting patients.

XIENCE 90 Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Atherosclerotic Heart Disease
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. = 75 years of age.
    2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
    3. History of major bleeding which required medical attention within 12 months of the index procedure.
    4. History of stroke (ischemic or hemorrhagic.
    5. Renal insufficiency (creatinine = 2.0 mg/dl) or failure (dialysis dependent).
    6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm3, or any known coagulation disorder associated with increased bleeding risk).
    7. Anemia with hemoglobin < 11g/dl.
    8. Subject must be at least 18 years of age.
    9. Subject or a legally authorized representative must provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
    10. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 3 months, if eligible per protocol.
    11. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
    12. Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note: • The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the patient must not have >2 lesionsrequiring treatment within both the LAD and a diagonal branch in total. • If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
    13. Target lesion = 32 mm in length by visual estimation.
    14. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
    15. Exclusive use of XIENCE family of stent systems during the index procedure.
    16. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection NHLBI grade = type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5 mm or depression lasting > 5 minutes.

You may not be eligible for this study if the following are true:

    1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
    2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
    3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 9 months prior to index procedure.
    4. Subject has a known left ventricular ejection fraction (LVEF) <30%.
    5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
    6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure.
    7. Subject with a current medical condition with a life expectancy of less than 12 months.
    8. 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.
    9. Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
    10. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
    11. Target lesion is in a left main location.
    12. Target lesion is located within an arterial or saphenous vein graft.
    13. Target lesion is restenotic from a previous stent implantation.
    14. Target lesion is a total occluded lesion (TIMI flow 0).
    15. Target lesion contains thrombus as indicated in the angiographic images (per SYNTAX score thrombus definition).
    16. Target lesion is implanted with overlapping stents, whether planned or for bailout. Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.