Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

Inclusion Criteria:

All subjects must meet the following criteria:

1. Subjects, male or female, must be at least 35 years of age at the time of consent. A
female of childbearing potential may be enrolled, provided she has a negative
pregnancy test within 7 days of screening.

2. Subjects must give written informed consent prior to participation in the study and
must understand the purpose of this study and be willing to adhere to the study
procedures described in this protocol.

3. Rutherford Classification Category 2-4

4. De novo lesion in the Femoropopliteal artery, including the entire extent of the
superficial femoral artery and the proximal portion of the popliteal artery extending
to the medial condyle 3 cm above the knee joint

5. Disease segment length ≤ 180 mm

6. >70% diameter stenosis and/or occlusion based on site-determined visual angiography

7. Patent ipsilateral iliac artery

8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with
no planned intervention

9. Target reference vessel diameter 3.5-7.5 mm.

10. Projected life expectancy of 12 months or greater

11. Patient is available for follow-up for 36 months and is willing and able to comply
with all follow-up requirements

12. Patient is willing and able to provide signed informed consent

Exclusion Criteria:

Any subject meeting any of the following criteria will be excluded from the study.

1. Target vessel previously treated with a stent

2. Target lesion within 1.5 cm of the ostium of the SFA

3. Rutherford Classification Category 0,1,5 or 6

4. Inability to tolerate antithrombotic or antiplatelet therapies

5. Pregnancy (female of child-bearing age confirmed pregnant)

6. Other comorbidity risks which in the opinion of the investigator limit longevity or
likelihood of complying with protocol follow up.

7. Serum creatinine > 2.5 mg/dL

8. Myocardial infarction or stroke within 30 days of treatment date

9. Known hypercoagulable state

10. Known bleeding diathesis

11. Untreated angiographically-evident thrombus in target vessel

12. Patients currently enrolled in any other clinical trial