A randomized trial comparing the ELUVIA* drug-eluting stent versus bare Metal self-expanding nitINol stEnts in the treatmeNt of superficial femoral and/or proximal popliteal arTeries

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Subjects age 18 and older
2. Subject is willing and able to provide consent before any study-specific
test or procedure is performed, signs the consent form, and agrees to attend
all required follow-up visits
3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2,
3 or 4
4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or
PPA:
a. Degree of stenosis *70% by visual angiographic assessment
b. Vessel diameter >= 4 and *6 mm
c. Total lesion length (or series of lesions) >= 30 mm and * 210 mm (Note:
Lesion segment(s) must be fully covered with one or two overlapping ELUVIA
stent(s) or Self Expanding Bare Nitinol stent(s))
d. For occluded lesions (chronic occlusions) requiring use of re-entry device,
lesion length <= 180 mm
e. Target lesion located at least three centimeters above the inferior edge of
the femur
5. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or
better with at least one of three vessels patent (<50% stenosis) to the ankle
or foot with no planned intervention

Exclusion Criteria

1. Previously stented target lesion/vessel
2. Target lesion/vessel previously treated with drug-coated balloon <12 months
prior to randomization/enrollment
3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb
to treat atherosclerotic disease
4. Use of atherectomy, laser or other debulking devices such as Rotarex in the
target limb SFA/PPA during the index procedure
5. History of major amputation in the target limb
6. Documented life expectancy less than 24 months due to other medical
co-morbid condition(s) that could limit the subject*s ability to participate in
the clinical study, limit the subject*s compliance with the follow-up
requirements, or impact the scientific integrity of the clinical study
7. Known hypersensitivity or contraindication to contrast dye that, in the
opinion of the investigator, cannot be adequately pre-medicated
8. Known hypersensitivity/allergy to the stent system or protocol related
therapies (e.g., nitinol, paclitaxel, or structurally related compounds,
polymer or individual components, and antiplatelet, anticoagulant, thrombolytic
medications)
9. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis
10. Concomitant renal failure with a serum creatinine >2.0 mg/dL
11. Receiving dialysis or immunosuppressant therapy
12. History of myocardial infarction (MI) or stroke/cerebrovascular accident
(CVA) within 6 months prior to randomization/enrollment
13. Unstable angina pectoris at the time of randomization/enrollment
14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years
15. Current participation in an investigational drug or device clinical study
that has not completed the primary endpoint at the time of randomization/
enrollment or that clinically interferes with the current study endpoints
(Note: studies requiring extended follow-up for products that were
investigational, but have become commercially available since then are not
considered investigational studies)
16. Septicemia at the time of randomization/enrollment
17. Presence of other hemodynamically significant outflow lesions in the target
limb requiring intervention at the time of the index procedure
18. Presence of aneurysm in the target vessel
19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to
randomization/enrollment.
20. Perforated vessel as evidenced by extravasation of contrast media prior to
randomization/enrollment.
21. Heavily calcified lesions.
22. As applicable by French law, subject who is a protected individual such as
an incompetent adult or incarcerated person.