Acrobat Coronary Stent System Effectiveness European Study (ACES)

Inclusion Criteria:

• Eligible for PCI and demonstrating native vessel or vein/arterial graft disease
• symptomatic CAD: either stable angina pectoris (CCS 1, 2, 3 pr 4) or unstable (Braunwald Class 1-3, B-C) or positive functional ischemia study
• Male and post-menopausal female
• Patient provides written informed consent prior to procedure
• Patient willing to comply with protocol
• Acceptable candidate for CABG
• Patient indicated for stenting of one or more de novo stenotic lesions in native coronary arteries or bypass grafts with or without direct stenting
• All target lesions for stenting in single or multi-vessel disease meet all inclusion criteria
• None of the lesions requires stenting with Drug eluting stents
• At least one lesion is visually estimated to be candidate for direct stenting
• All target lesions for stenting have a visually estimatd RVD >= 2.5 mm and <= 3.5 mm
• All target lesions for stenting are visually estimated to have LL =< 20 mm (to cover the lesion with 1 stent)
• All target lesions for stenting visually estimated to have a stenosis > 50% and < 99%
• All target lesions for stenting are ACS lesions TIMI flow >= 1

Exclusion Criteria:

• Currently enrolled in another clinical trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• A previous coronary procedure within 30 days
• Any of the target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
• Previous BMS deployment anywhere in the target vessel within the past 6 months
• Any DES deployment anywhere in the target vessel within the past 9 months
• Any previous stent placement within 10 mm (proximal or distal) of the target lesion
• Patient has diabetes mellitus
• Co-morbid condition(s) that could limit the patient's participation or impact the trial
• Documented LVEF < 30% at the most recent evaluation
• Evidence of AMI within 72 hours of the intended trial procedure and/or with TIMI flow 0
• History of CVA or TIA in the last 6 months
• Leukopenia (<3.5 x 10^9/L)
• Neutropenia (<1000/mm3) <= 3 days prior to enrollment
• Thrombocytopenia (<10^5/mm3) pre-procedure
• Active peptic ulcer or active GI bleeding
• History of bleeding diathesis or coagulopathy or inability to accept blood transfusions
• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated
• Serum creatinine level > 2.5 mg per dl within 7 days prior to index procedure
• In-stent restenosis
• Patient not able to give consent or read or write or protected by law or under guardianship or deprived of civil rights
• Woman of childbearing age
• Patient not covered by health or social insurance
• Unprotected left main CAD with obstruction > 50% , not protected by at least one non-obstructed bypass graft to the LAD or left circumflex (LCX) artery or their branches
• Target vessel exhibiting multiple lesions > 40% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) to be stented based on visual estimate or on-line QCA
• Any target lesion for stenting exhibits an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time
• Any target lesion for stenting is excessively tortuous (two bends > 90° to reach the target lesion)
• Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX
• Any target lesion for stenting is has side branches > 2.0 mm in diameter in which bifurcation stenting is planned
• Any target lesion >20 mm
• Any target lesion totally occluded (CTO)
• Any target lesion has TIMI flow = 0
• Any target lesion with ISR