Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access (RADIANCY)

This is an interventional treatment trial for Peripheral Arterial Disease Read More

Inclusion Criteria:

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

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. 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.
5. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach
6. Palpable radial artery with diameter ≥ 2.5 mm
7. Eligibility for standard surgical repair, if necessary
8. A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
9. The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
10. 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.

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 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) whose combined length less than or equal to 145 mm

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 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) whose combined length less than or equal to 170 mm

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. Poor aortoiliac or common femoral "inflow" (angiographically defined as > 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated (defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion

Exclusion Criteria:

Subjects will be excluded if they meet ANY of the following exclusion criteria:

1. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
2. 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).
3. Noted perforation of the target vessel
4. Previously deployed stent within the target vessel (if treating a lesion in the proximal popliteal or iliac arteries) or within the same segment of the target vessel (if treating a lesion in the SFA)
5. The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
6. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
7. Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
8. 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 procedures pre-determined to require stent-in-stent placement to obtain patency
9. 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
10. Presence of thrombus prior to crossing the lesion
11. The patient is receiving any form of dialysis.
12. The patient is receiving any form of immunosuppressant therapy.
13. Successful PTA treatment of a target lesion in the SFA/PPA (defined as ≤ 50% stenosis after PTA treatment)
14. Planned amputation
15. Established vasospastic disease
16. Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index procedure
17. The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
18. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
19. Bleeding diathesis
20. 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
21. Known allergy or intolerance to Nitinol (nickel titanium)
22. Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines
23. Known or suspected active infection at the time of the index procedure
24. 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.
25. 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. Interventional procedures performed to the ipsilateral iliac artery to provide access are allowed
26. If it is determined during percutaneous intervention that lesions apart from the target lesion require treatment, these lesions must be treated successfully prior to enrollment. An exception is if the target lesion is in the iliac artery and the investigator determines the patient will benefit from post-stent surgical treatment of the femoral and/or popliteal artery(s), (defined as fem-fem or fem-pop bypass) and it is reasonable to anticipate that additional complications will not be encountered.