The PzF Shield Trial

General Inclusion Criteria:

1. Patient >/= to 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).

Angiographic Inclusion Criteria

1. Patient indicated for elective stenting of a single stenotic lesion in a native
coronary artery.

2. Reference vessel >/= 2.5 mm and
3. Target lesion the whole lesion with one stent of adequate length).

4. Protected left main lesion with >50% stenosis.

5. Target lesion stenosis >/= 70% and < 100% by visual estimate.

6. Target lesion stenosis <70% who meet physiological criteria for revascularization
(i.e. positive FFR).

General 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 within the prior 2 years.

3. ANY planned elective surgery or percutaneous intervention within the subsequent 3
months.

4. A previous coronary interventional procedure of any kind within 30 days prior to the
procedure.

5. The patient requires staged procedure of either the target or any non-target vessel
within 9 months post-procedure.

6. The target lesion 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.).

7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.

8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.

9. 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.

10. Concurrent medical condition with a life expectancy of less than 12 months.

11. Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to
enrollment.

12. Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal
prior to enrollment) or suspected acute MI at time of enrollment

13. Previous brachytherapy in the target vessel.

14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.

15. Leukopenia (leukocytes < 3.5 x 10(9) / liter).

16. Neutropenia (Absolute Neutrophil Count < 1000/mm3)
17. Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.

18. Active peptic ulcer or active GI bleeding.

19. History of bleeding diathesis or coagulopathy or inability to accept blood
transfusions.

20. 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.

21. Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.

22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post
procedure.

Angiographic Exclusion Criteria

1. Unprotected left main coronary artery disease (obstruction greater than 50% in the
left main coronary artery that is not protected by at least one non-obstructed bypass
graft to the LAD or Circumflex artery or a branch thereof).

2. Target vessel with any lesions with greater than 50% diameter stenosis outside of a
range of 5 mm proximal and distal to the target lesion based on visual estimate or
on-line QCA.

3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the
true lumen diameter) at any time.

4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior
descending (LAD) or left circumflex (LCX).

5. Target lesion with side branches > 2.0mm in diameter.

6. Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).

7. Target lesion is severely calcified.

8. TIMI flow 0 or 1

9. Target lesion is in a bypass graft