ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

Completed · Not applicable

Conditions studied: Atherosclerosis of Native Arteries of the Extremities

In brief

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.

Key facts

Study ID: NCT02574481
Run by: Boston Scientific Corporation
People needed: 524
Starts: 2015-12-01
Expected to finish: 2022-04-12
Last updated by the study team: 2023-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects age 18 and older.
Subject (or Legal Guardian if applicable) 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. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.
Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.
Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA:
Degree of stenosis ≥ 70% by visual angiographic assessment
Vessel diameter ≥ 4 and ≤ 6 mm
Total lesion length (or series of lesions) ≥ 30 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents)
Long Lesion Substudy: Total lesion length (or series of lesions) >140 mm and ≤ 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents).
For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 mm
Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length > 120 mm and ≤ 170 mm
Target lesion located at least three centimeters above the inferior edge of the femur
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.

You may not qualify if…

Previously stented target lesion/vessel.
Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.
Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease.
Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure.
History of major amputation in the target limb.
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 trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial.
Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
Known hypersensitivity/allergy to the investigational stent system or protocol related therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual components, and antiplatelet, anticoagulant, thrombolytic medications).
Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
Concomitant renal failure with a serum creatinine >2.0 mg/dL.
Receiving dialysis or immunosuppressant therapy.
History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment.
Unstable angina pectoris at the time of randomization/enrollment.
Pregnant, breast feeding, or plan to become pregnant in the next 5 years.
Current participation in another 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).
Septicemia at the time of randomization/enrollment.
Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment.
Presence of aneurysm in the target vessel.
Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment.
Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment.
Heavily calcified lesions.

Where it is running

University of California, Davis Medical Center — Sacramento, California, United States
Florida Research Network, LLC — Gainesville, Florida, United States
First Coast Cardiovascular Institute — Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute — Miami, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
MediQuest Research at Munroe Regional Medical Center — Ocala, Florida, United States
Baptist Hospital — Pensacola, Florida, United States
University Hospital — Augusta, Georgia, United States
Advocate Christ Medical Center — Oak Lawn, Illinois, United States
St. Francis Medical Center — Peoria, Illinois, United States
St. Joseph Hospital — Fort Wayne, Indiana, United States
Maine Medical Center — Portland, Maine, United States
Steward St. Elizabeth's Medical Center of Boston, Inc. — Boston, Massachusetts, United States
Northern Michigan Hospital — Petoskey, Michigan, United States
Mercy Hospital — Coon Rapids, Minnesota, United States
Mayo Clinic Foundation — Rochester, Minnesota, United States
Alegent Creighton Health Bergan Mercy Medical Center — Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
New Mexico Heart Institute, PA — Albuquerque, New Mexico, United States
Maimonides Medical Center — Brooklyn, New York, United States
New York University Medical Center — New York, New York, United States
New York Presbyterian Hospital-Columbia University Medical Center — New York, New York, United States
Carolinas HealthCare System NorthEast — Concord, North Carolina, United States
Yuma Regional Medical Center — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

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