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

This is an interventional other trial for Ischemic Heart Disease focused on measuring Stent, interventional cardiology, catheterization, symptomatic ischemic heart disease Read More

Inclusion Criteria:

1. Patient >= 18 years old.
2. Eligible for Percutaneous Coronary Intervention (PCI).
3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
6. 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).
7. 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:

1. 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.
2. Previously enrolled in another stent trial in the previous 2 years.
3. ANY planned elective surgery or percutaneous intervention within subsequent 9 months.
4. A previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
5. The subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
6. Previous drug eluting stent (DES) deployment anywhere in the target vessel.
7. Any drug eluting stent (DES) deployment anywhere within the past 12 months
8. 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.
9. Concurrent medical condition with a life expectancy of less than 12 months.
10. 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.