XIENCE V: SPIRIT WOMEN Sub-study

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus Read More

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)