CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Inclusion Criteria: General Inclusion Criteria

1. Peripheral vascular disease Rutherford Classification 1, 2, or 3;

2. Eligible for revascularization of native vessel (PTA or bypass);

3. Willing and able to comply with the specified evaluations during hospitalization andall required follow-up examinations;

4. Written informed consent given before execution of study procedures; and

5. Age > 18 and ≤ 85 years. Angiographic Inclusion Criteria

6. Reference vessel diameter >/= 4.0 mm and ≤ 7.0 mm as determined by physician visualangiographic assessment of the most normally appearing vessel segment within 10 mmproximal AND 10 mm distal to the target segment.

7. Stenosis within the SFA and/or popliteal artery above the knee of >/= 70% and </= 100%DS (occlusion), as determined by visual angiographic assessment by the investigator atthe time of the procedure and documented by angiography in at least two (2) orthogonalviews.

8. At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.

9. Total lesion length >/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographicassessment at the time of the procedure, separate multiple lesions can be combined astwo separate treatment areas as long as the sum total of all lesion lengths and/ortreatment areas does not exceed 1.0 cm to 15.0 cm.

10. Patency (< 50% DS) of at least one (1) infrapopliteal artery in continuity with thenative femoropopliteal artery.

Exclusion Criteria: General Exclusion Criteria

1. Contraindication to intravenous contrast material, heparin, aspirin or othermedications required for a percutaneous interventional procedure;

2. Known bleeding or hyper-coagulation disorder;

3. Serum creatinine > 2.0 mg/dL;

4. Uncompensated congestive heart failure;

5. Current enrollment in any investigational study wherein patient participation has notbeen completed;

6. Prior enrollment in this study;

7. Suspected or confirmed pregnancy;

8. Any patient, who in the opinion of the investigator, would not be a good candidate forenrollment;

9. Myocardial infarction within 60 days; and

10. CVA/TIA within 60 days. Angiographic Exclusion Criteria

12. Subintimal guidewire placement following pilot channel creation through a stenosis orocclusion with any excimer laser catheter, as visualized with IVUS;

13. Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath®Photoablation Atherectomy system;

14. Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated priorto enrollment in this study;

15. Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollmentwith final residual stenosis >/= 30%, as determined in at least two (2) orthogonalviews and documented by angiography;

16. Iliac treatment prior to enrollment where a perforation occurred requiring a coveredstent, blood transfusion, or surgery for treatment of the perforation;

17. Identification of any lesion above the knee and/or below the knee in the treated leg (ipsilateral) that will require preplanned or predicted treatment within six (6)months after enrollment and prior to the completion of the six (6) month follow-up,including the iliac artery, the common femoral artery, the peroneal, anterior tibial,or posterior tibial arteries, or any area from the iliacs to the foot outside of thetreatment area;

18. Lesions proximal and distal to the treatment site that are >/= 50% DS at time ofenrollment;

19. Contralateral leg disease that requires treatment within the next 30 days and prior tocompletion of the 30 day follow-up;

20. Cardiovascular surgical or cardiovascular interventional procedures (including, butnot limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee)within 30 days prior to enrollment in this study;

21. Planned or predicted cardiovascular surgical or interventional procedures outside ofthe ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid,contralateral femoro-popliteal, and contralateral below the knee) within 30 days afterentry into this study, and prior to completion of the 30-day follow-up; and

22. Perforation or dissection of grade "C" or greater seen during or after the creation ofthe pilot channel.