Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

This is a prospective, multicenter, non-randomized, single arm, pivotal trial.

The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.

Inclusion Criteria:

1. Age greater than or equal to 18 years and of age of legal consent.
2. Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
3. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index (ABI) less than or equal to 0.9. TBI (toe-brachial index) is performed only unable to assess ABI. TBI must be less than or equal to 0.7.
4. A single superficial femoral artery lesion with greater than 60% stenosis or total occlusion.
5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) greater than or equal to 40 mm to less than or equal to 140 mm. Reference vessel diameter (RVD) greater than or equal to 4.0 mm and less than or equal to 6.0 mm by visual assessment.
6. All lesions are to be located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda artery.
7. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50% stenosis) to the ankle or foot.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
9. Poor aortoiliac or common femoral "inflow" (i.e., angiographically defined greater than 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as less than 30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, the pressure gradient across the target lesion will be obtained and if the pressure gradient is greater than or equal to 20 mmHg, then the subject will be included in the study.
10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure (staged); however, if contralateral treatment is performed prior to treatment of the target lesion, the waiting period will be at least 14 days prior to the index procedure.
11. The subject is eligible for standard surgical repair, if necessary.
12. A subject who requires a coronary intervention should have it performed at least 7 days prior to the treatment of the target lesion.
13. Subject must provide written informed consent.
14. Subject must be willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.

2. Receiving dialysis or immunosuppressant therapy within the previous 30 days.

3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

4. Stroke within the previous 90 days.

5. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.

6. Required stent placement via a popliteal approach.

7. Required stent placement across or within 0.5 cm of the SFA/PFA bifurcation.

8. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.

9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.

10. Required stent placement within 1 cm of a previously deployed stent.

11. Subject required a coronary intervention, and the coronary intervention was done less than 7 days prior to or planned within 30 days after the treatment of the target lesion.

12. Known allergies to any of the following: aspirin and all three of the following: clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), and prasugrel (Effient®); heparin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.

13. Presence of thrombus prior to crossing the lesion.

14. Known or suspected active infection at the time of the procedure.

15. Presence of an ipsilateral arterial artificial graft.

16. Use of cryoplasty, laser, or atherectomy devices at the time of index procedure.

17. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.

18. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.

19. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.

20. Known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0) that cannot be corrected.

21. Subject has the following laboratory values:

    1. platelet count less than 80,000/μL,
    2. international normalized ratio (INR) greater than 1.5,
    3. serum creatinine level greater than 2.0 mg/dL.

22. Subject requires general anesthesia for the procedure.

23. Subject is pregnant or plans to become pregnant during the study.

24. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.

25. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.