PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)

This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure.

The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.

Inclusion criteria

• Patient >= 18 years old.
• Eligible for Percutaneous Coronary Intervention (PCI).
• Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
• Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
• Acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
• Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Exclusion criteria

• Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• Previously enrolled in another stent trial in the previous 2 years.
• ANY planned elective surgery or percutaneous intervention within subsequent 9 months.
• A previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
• The subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
• Previous drug eluting stent (DES) deployment anywhere in the target vessel.
• Any drug eluting stent (DES) deployment anywhere within the past 12 months
• Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
• Concurrent medical condition with a life expectancy of less than 12 months.
• 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.