Untersuchung der Sicherheit und Funktion eines neuen Stentsystems das durch die Unterarmarterie eingesetzt werden kann und durch die Blutgefässe in den Oberschenkelbereich gebracht werden kann.

Device: S.M.A.R.T. RADIANZ? Vascular Stent System;Device: BRITE TIP RADIANZ? Guiding Sheath;Device: SABERX RADIANZ? PTA Balloon Catheter

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:

ALL patients must meet the following criteria prior to enrollment:

1. Age = 18 years

2. For women of child-bearing potential, a negative pregnancy test within seven (7) days
prior to the index procedure

3. Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot
(Rutherford/Becker Classification category 2, 3, 4 or 5)

4. Palpable radial artery with diameter = 2.5 mm, as assessed by duplex ultrasound

5. Eligibility for standard surgical repair, if necessary

6. A patient who requires a coronary intervention should have it performed at least seven
(7) days prior to treatment of the target lesion

7. The patient must provide documented informed consent and any other documented
authorization, as required, prior to initiation of the study procedure

8. Per Investigator assessment, the patient is willing and able to be followed up to 30
days post-procedure for evaluation and complete all required assessments per the study
protocol.

Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is
applicable) would be assessed via baseline angiography performed at the time of index
procedure:

9. The Investigator has assessed that the patient is a suitable candidate (i.e, meets all
inclusion criteria and none of the exclusion criteria), for treatment of a lesion in
the iliac, superficial femoral and/or proximal popliteal arteries via transradial
approach and is eligible for conversion from a transradial to transfemoral approach,
if it becomes necessary.

10. The guidewire is across the target lesion(s) and located intraluminally within the
distal vessel following a transradial approach

Patients whose target lesion is in the iliac artery must meet these additional criteria
prior to enrollment:

11a. A single de novo or restenotic lesion = 50% stenosis in the common and/or external
iliac artery

12a. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 100
mm, by visual assessment, within or across the common or external iliac arteries. The
stenosis must be treatable with no more than two stents (while minimizing stent overlap)

13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment

14a. Angiographic evidence of a patent profunda or superficial femoral artery in the
diseased (target) limb

Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria
prior to enrollment:

11b. A single de novo or restenotic lesion = 50% stenosis in the SFA and/or PPA

12b. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 150
mm, by visual assessment, within or across the SFA and/or PPA. The stenosis must be
treatable with no more than two stents (while minimizing stent overlap)

13b. RVD ranging from 4.0 to 7.0 mm by visual assessment

14b. All lesions are to be located at least three centimeters proximal to the superior edge
of the patella

15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (<50%
stenosis) of at least one of three vessels to the ankle or foot

16b. Adequate aortoiliac or common femoral "inflow" (defined as < 30% stenosis after PTA or
stenting) prior to treatment of the target lesion (defined as < 30% stenosis after PTA or
stenting) prior to treatment of the target lesion

Exclusion Criteria:

Patients will be excluded if ANY of the following exclusion criteria apply:

1. The patient has had/experienced any prior intervention/treatment to the target vessel
within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or
target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or
aneurysm of the iliac, superficial femoral or popliteal artery).

2. Previously deployed stent at the site of the target lesion

3. The patient has post-surgical stenosis and anastomotic suture treatments of the target
vessel

4. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the
stenting procedure

5. Use of mechanical devices on or thrombolysis of the target vessel within 72 hours
prior to the index procedure without complete resolution of the thrombus

6. The patient is receiving any form of dialysis.

7. The patient is receiving any form of immunosuppressant therapy.

8. Planned amputation

9. Established vasospastic disease

10. Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index
procedure

11. The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.

12. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the
index procedure

13. Bleeding diathesis

14. Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic
medications including but not limited to aspirin, clopidogrel bisulfate (Plavix?),
ticlopidine (Ticlid?) or heparin that cannot be medically managed.

15. Known allergy or intolerance to Nitinol (nickel titanium)

16. Known allergy to contrast agent that cannot be medically managed before treatment with
steroids and/or antihistamines.

17. Known or suspected active infection at the time of the index procedure.

18. Patient is currently participating in another investigational drug or medical device
study that has not completed primary endpoint(s) evaluation or clinically interferes
with the endpoints from this study or is planning to participate in such a study prior
to their completion of this study.

19. Patient has had a major surgical or interventional procedure unrelated to this study
within 30 days prior to enrollment or is anticipated/planned to have such a procedure
within 30 days after enrollment.

Exclusion criteria 20 through 25 would be assessed via baseline angiography performed
at the time of index procedure:

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

21. Noted perforation of the target vessel

22. Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery
(PFA) bifurcation

23. Cases of chronic total occlusion/in-stent restenosis/severe calcification in which
there is pre-determined inability to treat the target lesion with a single stent, or
procedur