XIENCE V: SPIRIT WOMEN Sub-study
Condition: Coronary Artery Stenosis; Coronary Arteriosclerosis; Coronary Artery Disease; Coronary Artery Restenosis; Total Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Thrombosis; Vascular Diseases; Arteriosclerosis; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia
Intervention: XIENCE V®/ XIENCE PRIME™; CYPHER SELECT
Intervention description: Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System; XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 455.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stents; Angioplasty; Total coronary occlusions; Coronary restenosis; Stent thrombosis; Everolimus

Summary:

      The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus
      Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on
      clinical outcomes in the treatment of female patients with de novo coronary artery lesions,
      and the characterization of the female population undergoing stent implantation with a XIENCE
      stent.
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Patient must be female.

          -  Patient must be at least 18 years of age.

          -  Patient is able to verbally confirm understanding of risks, benefits and treatment
             alternatives and she or 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.

          -  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).

          -  Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
             surgery.

          -  Patient must agree to undergo all protocol-required follow-up examinations.

          -  Patients of childbearing potential must have had a negative pregnancy test within 7
             days before treatment, and must not be nursing at the time of treatment.

        Angiographic Inclusion Criteria:

          -  Patients' artery morphology and disease is suitable to be optimally treated with a
             maximum of 4 planned study stents.

          -  Target lesions must be de novo lesions (no prior stent implant, no prior
             brachytherapy).

          -  Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.
             The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.

          -  Target lesion greater than or equal to 28 mm in length by visual estimate.

        General Exclusion Criteria:

          -  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 clinical investigation plan, confound the data interpretation
             or is associated with a limited life expectancy (i.e., less than one year).

          -  Patient has a known hypersensitivity or contraindication to aspirin, either heparin or
             bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
             tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
             adequately pre-medicated.

          -  Participation in another device or drug study or has completed the follow-up phase of
             another study within the last 30 days.

          -  Patient who is judged to have a lesion that prevents complete inflation of an
             angioplasty balloon.

          -  Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug
             Eluting Stent (DES) within the target vessel(s)