SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Condition: Coronary Disease; Coronary Artery Disease; Coronary Restenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis
Intervention: TAXUS® Liberté™; XIENCE V® EECSS
Intervention description: Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes; Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug eluting stents; stents; Angioplasty; coronary artery disease; total coronary occlusion; coronary artery restenosis; stent thrombosis; vascular disease; myocardial ischemia; coronary artery stenosis

Summary:

      The purpose of this Clinical Evaluation is a continuation in the assessment of the
      performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in
      the treatment of patients with de novo coronary artery lesions in patients (Diabetic
      sub-study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years

          -  able to verbally confirm understanding of risks, benefits and treatment alternatives
             of receiving the XIENCE V® EECSS and he/she or his/her legally authorized
             representative provides written informed consent prior to any study related procedure,
             as approved by the appropriate Medical Ethics Committee of the respective clinical
             site

          -  diagnosed with diabetes, as documented by medical history.

          -  evidence of myocardial ischemia

          -  acceptable candidate for coronary artery bypass grafting (CABG) surgery

          -  agree to undergo all clinical investigation plan (CIP)-required follow-up examinations

          -  artery morphology and disease is suitable to be optimally treated with a maximum of 4
             planned stents

          -  maximum of one, de novo, target lesion per native major epicardial vessel or side
             branch

          -  target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate

          -  target lesion ≤ 28 mm in length by visual estimate

          -  target lesion must be in a major artery or branch with a visually estimated stenosis
             of > 50% and < 100% and a TIMI flow > 1

        Exclusion Criteria:

          -  known diagnosis of acute myocardial infarction within 72 hours preceding the index
             procedure

          -  current unstable arrhythmias

          -  Left ventricular ejection fraction < 30%

          -  received a heart or any other organ transplant or is on a waiting list for any organ
             transplant

          -  receiving or scheduled to receive chemotherapy or radiation therapy within 30 days
             prior to or after the procedure.

          -  receiving immunosuppression therapy or has known immunosuppressive or autoimmune
             disease

          -  known hypersensitivity or contraindication to specific agents

          -  elective surgery is planned within the first 9 months after the procedure that will
             require discontinuing either aspirin or clopidogrel

          -  platelet count limits, white blood cell limits or documented or suspected liver
             disease

          -  renal insufficiency

          -  history of bleeding diathesis or coagulopathy or will refuse blood transfusions

          -  Cerebrovascular accident or transient ischemic attack within the past 6 months

          -  significant GI or urinary bleed within the past 6 months

          -  history of other medical illness (e.g., cancer or congestive heart failure) or known
             history of substance abuse that may cause non-compliance with the CIP, confound the
             data interpretation or is associated with a limited life expectancy (i.e. less than
             one year)

        Target lesion meets any of the following criteria:

          -  In-stent restenotic

          -  aorto-ostial location (within 3 mm)

          -  left main location

          -  located within 2 mm of the origin of the left anterior descending artery (LAD) or left
             circumflex artery (LCX)

          -  located within an arterial or saphenous vein graft or distal to a diseased arterial or
             saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed
             lesion by visual estimation)

          -  lesion involving a side branch ≥ 2.5 mm in diameter

          -  lesion involving a side branch with > 50% stenosis by visual estimation Lesion
             involving a side branch requiring predilatation

          -  located in a major epicardial vessel that has been previously treated with
             brachytherapy

          -  located in a major epicardial vessel or a side branch that has been previously treated
             with any type of percutaneous intervention (e.g., balloon angioplasty, cutting
             balloon, atherectomy), < 9 months prior to the index procedure

          -  total occlusion (TIMI flow 0), prior to wire crossing

          -  excessive tortuosity proximal to or within the lesion

          -  extreme angulation (≥ 90%) proximal to or within the lesion

          -  heavy calcification

        The target vessel contains visible thrombus

        Patient has a high probability that a procedure other than pre-dilatation, stenting and
        post-dilatation will be required at the time of index procedure for treatment of the target
        vessel (e.g. brachytherapy)

        Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a
        target vessel or side branch for which an intervention within 9 months after the index
        procedure may be required