SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Condition: Stents; Coronary Artery Disease; Total Coronary Occlusion; Coronary Artery Restenosis; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Thrombosis; Vascular Diseases; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia
Intervention: XIENCE V® Everolimus Eluting Coronary Stent; TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
Intervention description: Drug eluting stent implantation stent in the treatment of coronary artery disease.; Drug eluting stent implantation stent in the treatment of coronary artery disease.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1002.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Everolimus

Summary:

      This study is divided into 5 arms:

        1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single
           blind, parallel two-arm multi-center clinical trial in the United States (US) comparing
           XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter
           stents) to the Food and Drug Administration (FDA) approved commercially available active
           control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS)
           System

        2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS

        3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS

        4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS

        5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0
           mm diameter stents) in Japan

      The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston
      Scientific.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Target lesion(s) must be located in a native epicardial vessel with visually estimated
             diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm

          -  The target lesion(s) must be in a major artery or branch with a visually estimated
             stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow
             of >= 1

          -  Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if
             done >= 90 days prior to the index procedure (subjects who received brachytherapy will
             be excluded from the trial)

        Exclusion Criteria:

          -  Located within an arterial or saphenous vein graft or distal to a diseased (vessel
             irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or
             saphenous vein graft

          -  Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by
             visual estimation or side branch requiring predilatation

          -  Located in a major epicardial vessel that has been previously treated with
             brachytherapy

          -  Located in a major epicardial vessel that has been previously treated with
             percutaneous intervention < 9 months prior to index procedure

          -  Total occlusion (TIMI flow 0), prior to wire passing

          -  The target vessel contains thrombus

          -  Another significant lesion (> 40% diameter stenosis [DS]) is located in the same
             epicardial vessel as the target lesion