EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease
Condition: Coronary Disease; Coronary Artery Disease; Coronary Artery Stenosis; Coronary Artery Restenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis; Coronary Restenosis
Intervention: XIENCE V® Everolimus Eluting Coronary Stent System; TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Intervention description: Coronary artery placement of a drug-eluting stent; Coronary artery placement of a drug-eluting stent
Intervention MeSH terms: Paclitaxel; Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stents; Drug-eluting Stent; Angioplasty; Coronary Artery stenosis; Coronary Artery Stent Restenosis; Stent Thrombosis

Summary:

      The purpose of this two part study is the assessment of the performance of the XIENCE V®
      Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific
      setting of patients with Multi-Vessel Coronary Artery Disease (MVD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be at least 18 years of age

          2. Patient is 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

          3. Patient has been diagnosed a MVD, as documented by coronary angiography, i.e.
             presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial
             vessels or their principal bifurcation branches (diagonal or obtuse marginal)

          4. Patient 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)

          5. Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
             surgery

          6. Patient must agree to undergo all protocol-required follow-up examinations.

        Angiographic Inclusion Criteria

          1. Patients may receive up to 4 planned XIENCE V® EECSS stents, depending on the number
             of vessels treated and their respective lesion length. When multiple lesions are
             present in one or more main coronary branches, complete revascularization should be
             attempted with the implantation of a maximum of 4 planned stents

          2. Target lesions must be de novo lesions (no prior stent implant, no prior
             brachytherapy)

          3. Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate

          4. Target lesion < or = 28 mm in length by visual estimation

          5. Target lesions must be in a major artery or its principal branches (diagonal or obtuse
             marginal) with a visually estimated stenosis of > or = 50%

          6. Two lesions in a single main coronary artery or its branches do not constitute a MVD
             situation, therefore this type of patient must not be enrolled

        Exclusion Criteria:

          1. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours
             preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times
             upper limit of normal) and CK and CK-MB have not returned within normal limits at the
             time of procedure

          2. Patient has current unstable arrhythmias

          3. Patient has a known left ventricular ejection fraction (LVEF) <30%

          4. Patient has received a heart transplant or any other organ transplant or is on a
             waiting list for any organ transplant

          5. Patient is receiving or scheduled to receive chemotherapy or radiation therapy within
             30 days prior to or after the procedure.

          6. Patient is receiving immunosuppression therapy or has known immunosuppressive or
             autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus
             etc.)

          7. Patient is receiving chronic anticoagulation therapy (e.g. coumadin)

          8. Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel,
             either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt,
             chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that
             cannot be adequately pre-medicated

          9. Elective surgery is planned within the first 9 months (+/- 14 days) after the
             procedure that will require discontinuing either aspirin or clopidogrel

         10. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000
             cells/mm3, or documented or suspected liver disease (including laboratory evidence of
             hepatitis)

         11. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5
             mg/dl, patient on dialysis)

         12. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood
             transfusions

         13. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological
             attack (TIA) within the past six months

         14. Patient has had a significant GI or urinary bleed within the past six months

         15. Patient 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)

         16. Patient is already participating in another investigational use device or drug study
             or has completed the follow-up phase of another study within the last 30 days.

        Angiographic Exclusion Criteria

          1. Target lesion meets any of the following criteria:

               -  Left main location

               -  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)

               -  Heavy calcification

          2. The patient may need more than 4 planned stents. Bailout stents are allowed but must
             be of the same type as randomization stent.