SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
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: 3687.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stents; Angioplasty; Total coronary occlusion; coronary restenosis; stent thrombosis

Summary:

      The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and
      efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V®
      arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™
      Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston
      Scientific.

      TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston
      Scientific.
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Subject must be at least 18 years of age

          -  Subject is able to verbally confirm understanding of risks, benefits and treatment
             alternatives of receiving XIENCE V® and he/she or his/her legally authorized
             representative provides written informed consent prior to any study related procedure

          -  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)

          -  Subject must be an acceptable candidate for coronary artery bypass graft (CABG)
             surgery

          -  Subject must agree to undergo all protocol-required follow-up procedures

          -  Subject must agree not to participate in any other clinical study for a period of one
             year following the index procedure

        Angiographic Inclusion Criteria:

          -  Target lesion(s) must be located in a native coronary artery with visually estimated
             diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions,
             maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to
             ≤3.75 mm until 4.0 mm TAXUS® is commercially available)

          -  Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of
             non-diseased tissue on either side of the target lesion should be covered by the study
             stent)

          -  If more than one target lesion will be treated, the RVD and lesion length of each must
             meet the above criteria

          -  If more than one target lesion will be treated, the RVD and lesion length of each must
             meet the above criteria

          -  The target lesion(s) must be in a major artery or branch with a visually estimated
             stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1

          -  Non-study, percutaneous intervention for lesions in a target vessel (including side
             branches) is allowed if done ≥ 9 months prior to the index procedure

          -  Non-study percutaneous intervention for lesions in a non-target vessel involving:

          -  Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3
             flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal
             stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser
             treatments are allowed if done ≥ 24 hours prior to the index procedure or during
             (before randomization) the index procedure. For interventions done within 24 to 48
             hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the
             upper limit of normal at the time of the index procedure. NOTE: Procedures within the
             24 hour period preceding the index procedure are not permitted

          -  Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon,
             atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to
             the index procedure

          -  Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure

          -  Non-study, percutaneous interventions for lesion(s) in a target vessel (including side
             branches) or non-target vessel are allowed if done ≥ 9 months after the index
             procedure

        General Exclusion Criteria:

          -  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 within normal limits at the time of procedure

          -  The subject is currently experiencing clinical symptoms consistent with AMI

          -  Subject has current unstable arrhythmias

          -  Subject has a known left ventricular ejection fraction (LVEF) < 30%

          -  Subject has received a heart transplant or any other organ transplant or is on a
             waiting list for any organ transplant

          -  Subject is receiving or scheduled to receive anticancer therapy for malignancy within
             30 days prior to or after the procedure

          -  Subject is receiving immunosuppression therapy, or has known serious immunosuppressive
             disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that
             requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)

          -  Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g.,
             heparin, coumadin)

          -  Subject has a known hypersensitivity or contraindication to aspirin, both heparin and
             bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
             tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
             adequately pre-medicated

          -  Elective surgery that will require discontinuing either aspirin or clopidogrel is
             planned within the first 9 months after the procedure

          -  Subject 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)

          -  Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or
             subject on dialysis)

          -  Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
             transfusions

          -  Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological
             attack (TIA) within the past six months

          -  Subject has had a significant GI or urinary bleed within the past six months

          -  Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
             insertion

          -  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 life expectancy of less than one year

          -  Subject is already participating in another clinical study that has not yet reached
             its primary endpoint

          -  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 and effective
             contraception must be used up to 1 year following the index procedure)

          -  Angiographic Exclusion Criteria

          -  The target lesion(s) meets any of the following criteria:

          -  Left main coronary artery location including left main ostial location (NOTE:
             RCA-aorto-ostial lesions are not excluded)

          -  Located within 2 mm of the origin of the LAD or LCX

          -  Located within an arterial or saphenous vein graft or distal to a diseased (vessel
             irregularity per angiogram and any visually estimated diameter stenosis > 20%)
             arterial or saphenous vein graft

          -  Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium
             of the side branch is > 50% stenosed by visual estimation

          -  Involves a side branch requiring pre-dilatation

          -  Total occlusion (TIMI flow 0) prior to wire crossing

          -  Excessive tortuosity proximal to or within the lesion

          -  Extreme angulation (≥ 90º) proximal to or within the lesion

          -  Heavy calcification

          -  Restenotic from previous intervention

          -  Subject has received brachytherapy in any epicardial vessel (including side branches)

          -  The target vessel contains thrombus

          -  Another clinically significant lesion in the target vessel is present that requires or
             has a high probability of requiring PCI during the index procedure

          -  Another lesion in a target or non-target vessel (including all side branches) is
             present that requires or has a high probability of requiring PCI within 9 months after
             the index procedure